Transepidermal water loss

Abstract

To provide a method and a device for evaluating a tissue structure in a damaged tissue or a tissue being healed.SOLUTION: Provided is a method for evaluating a transepidermal water loss (TEWL) measurement result in a tissue under intact skin of a patient. The method includes steps of a) acquiring TEWL measurement scan on the skin of the patient, and b) generating a TEWL measurement map.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 936,380, filed November 15, 2019, and U.S. Provisional Patent Application No. 63 / 110,356, filed November 6, 2020, the entire contents of each of which are incorporated herein by reference.

[0002] The present disclosure provides methods and devices for assessing tissue structure in damaged or healing tissue. The present disclosure also provides methods for identifying patients at risk for or at risk of developing a pressure ulcer and treating them with selected anatomy-specific clinical interventions based on transepidermal water loss. The present disclosure also provides methods for stratifying patient groups based on risk for wound development and methods for reducing the incidence or severity of tissue damage in institutionalized patients. The present disclosure also provides methods for detecting tissue damage before it becomes visible on a patient's skin. [Background technology]

[0003] Skin is the largest organ in the human body. It is susceptible to many types of damage and injury. Skin damage and injury occur when the skin and surrounding tissues are unable to redistribute external pressure and mechanical forces, which can lead to the formation of ulcers. Even moderate pressure, such as the pressure generated on the dorsal skin surface by the weight of a supine patient, can cause pressure ulcers if exposed continuously for extended periods of time. In the presence of other damage, such as neuropathy and peripheral tissue weakening that can be induced by diabetes, even regular exposure to even moderate levels of pressure and stress can lead to ulcers (e.g., foot ulcers).

[0004] Pressure ulcers affect approximately 2.5 million people annually in the United States and a similar number in the European Union. In long-term critical care settings, up to 25% of elderly, immobile patients develop pressure ulcers. Infections and other complications from pressure ulcers are responsible for approximately 60,000 patient deaths annually in the United States.

[0005] Most pressure ulcers develop over bony prominences where there is less tissue to compress and altered pressure gradients within the vascular network. Pressure ulcers are classified into one of six stages, ranging from the earliest recognized stage (redness over bony prominences with intact skin) (Stage 1), through tissue breakdown exposing bone, tendon, or muscle (Stage 4), to deep tissue pressure injury manifesting as non-blanching crimson, maroon, or purple discoloration, and finally, to full-thickness, indistinct skin and tissue loss (Unclear). Detecting and treating pressure ulcers before skin breakdown to prevent progression to later stages is a goal of policymakers and healthcare providers in major economies. Most pressure ulcers are preventable; if identified before the first stage of ulceration, deterioration of the underlying tissue can be halted.

[0006] Detecting tissue damage before the skin breaks and intervening with appropriate therapy to prevent further deterioration of the underlying tissue is desirable for both patients and society. The cost of treating pressure injuries averages approximately $2,000 for the earliest visible signs (stage 1 ulcers) but rises to $129,000 for ulcers deep enough to expose muscle or bone (stage 4 ulcers). See, for example, Brem, H. et al. (2010). High Cost of Stage IV Pressure Ulcers. Am. J. Surg. Oct; 200(4):473-477. Currently, patients typically receive universal pressure ulcer prevention, which means that prevention does not target specific anatomical locations. Patients receive targeted, localized ulcer treatment only after the ulcer has progressed to a point where it can be identified by visual assessment. Current criteria for detecting pressure ulcers rely on visual inspection, which is subjective, unreliable, premature, and lacks specificity. See, for example, Pancorbo-Hidalgo P. et al. (2006). Risk assessment scales for pressure ulcer prevention: a systematic review. Journal of Advanced Nursing, 54, 94-110 and Garcia-Fernandez, FP (2014). Predictive Capacity of Risk Assessment Scales and Clinical Judgment for Pressure Ulcers: A Meta-analysis. Journal of Wound, Ostomy and Continence Nursing, 41, 24-34. As a result, patients often experience skin inflammation, a precursor to ulcer development, but do not receive targeted localized treatment for the ulcer. Instead, the inflammation progresses and develops into a full-blown ulcer.

[0007] Skin damage and injury can also be the result of certain surgical procedures (e.g., reconstructive surgery involving skin flaps) that sever blood vessels in or around the surgical area. Healing of damaged or separated tissue depends on the restoration of adequate blood flow throughout the damaged area. Determining whether an area of ​​tissue has healed, i.e., whether blood flow through the tissue has increased to normal levels, is difficult by visual inspection. Existing devices can measure certain attributes, such as blood oxygen concentration, but these are only indirect measures of blood flow.

[0008] Transepidermal water loss (TEWL) is an objective measurement for assessing the skin's barrier function. TEWL is the amount of condensed water that diffuses to the skin surface across a given area of ​​the stratum corneum per unit time. Water evaporating from the skin is measured using a probe that contains a sensor that detects changes in water vapor density and is placed in contact with the skin surface. Summary of the Invention

[0009] Non-invasive, objective measurements provide a systematic method for identifying the onset of pressure ulcer risk before visible skin breakdown occurs, followed by targeted interventions to specific anatomy. Also, non-invasive, objective measurements provide a systematic method for identifying the onset of pressure ulcer risk before visible skin breakdown occurs, followed by targeted interventions to specific anatomy. Methods for monitoring wound healing progress and consistency of intervention compliance are further provided.

[0010] In one aspect, the present disclosure provides and encompasses a method for evaluating TEWL measurements in tissue beneath intact skin of a patient, the method comprising obtaining TEWL measurements at multiple locations on the patient's skin and generating a TEWL measurement map.

[0011] In one aspect, the present disclosure provides and encompasses a method of reducing the incidence of tissue injury in a patient admitted to a healthcare facility, the method comprising: assessing the patient for risk of tissue injury upon admission to the healthcare facility, and implementing a Level 0 intervention if the average TEWL value is below a first threshold, and implementing a Level N intervention (N is an integer equal to or greater than 1) if the average TEWL value is above the first threshold. In one aspect, the assessing step comprises obtaining TEWL measurements of the patient at one or more body locations at risk for wound development and determining an average TEWL value of the TEWL measurements.

[0012] In one embodiment, the one or more body areas at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of a patient. In one embodiment, the one or more body areas at risk for wound development include one or more anatomical sites that are in prolonged contact with a medical device. In one embodiment, the body area at risk for wound development is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0013] In one aspect, the present disclosure provides and encompasses a method for stratifying a plurality of patients in a healthcare facility based on level of care, the method including the steps of obtaining a TEWL measurement result of one of the plurality of patients at one or more body locations selected for monitoring, determining an average TEWL value of the TEWL measurements of the patient, determining a healthcare level among N levels of care that corresponds to the average TEWL value, assigning a healthcare level to the patient, and placing the patient among the plurality of patients into groups based on their respective assigned levels of care.

[0014] In one embodiment, the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of a patient. In one embodiment, the one or more body locations at risk for wound development include one or more anatomical sites in prolonged contact with a medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0015] In one aspect, the present disclosure provides and encompasses a method of identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method including the steps of obtaining a plurality of TEWL measurements of the patient at one or more body locations, determining an average TEWL value of the plurality of TEWL measurements of the patient, administering one or more anatomical-specific interventions based on the average TEWL value, increasing the level of the anatomical-specific intervention based on an increase in the average TEWL value, and decreasing the level of the anatomical-specific intervention based on a decrease in the average TEWL value.

[0016] In one aspect, the present disclosure provides and encompasses a method for assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, the method including the steps of obtaining initial TEWL measurements at one or more body locations selected for monitoring, determining an average TEWL value of the TEWL measurements, and assigning the patient to a risk category selected from the plurality of risk categories based in part on the average TEWL value of the TEWL measurements.

[0017] In one embodiment, the body site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of a patient. In one embodiment, the body site includes one or more anatomical sites in prolonged contact with a medical device and is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0018] In one aspect, the present disclosure provides and encompasses a method of managing the medical care of a patient, the method including the steps of obtaining a first set of TEWL measurements at one or more body locations selected for monitoring upon admission to a medical care facility; determining a first average TEWL value for each of the first set of TEWL measurements; if one of the average TEWL values ​​in the first set of TEWL measurements exceeds a first threshold, setting an intervention level N=1; implementing level N of intervention for each of the one or more body locations whose average TEWL value exceeds the first threshold; obtaining subsequent sets of TEWL measurements at each of the one or more body locations at a frequency of level N; and determining a new average TEWL value for each of the one or more body locations.

[0019] In one embodiment, the one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient. In one embodiment, the one or more body locations selected for monitoring include one or more anatomical sites in prolonged contact with the medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0020] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient at risk for tissue damage, the method comprising: assessing a patient for risk of tissue damage upon admission to a healthcare facility; implementing a first intervention at Level 0 if a first average TEWL value is less than or equal to a first threshold; and implementing a first intervention at Level N (N is an integer greater than or equal to 1) if the first average TEWL value is greater than the first threshold. In one aspect, the assessing step comprises obtaining a first plurality of TEWL measurements of the patient and determining a first average TEWL value of the initial set of TEWL measurements.

[0021] In one aspect, the method further includes obtaining a second plurality of TEWL measurements of the patient at a first predetermined frequency corresponding to the level of intervention implemented; determining a second average TEWL value of the second plurality of TEWL measurements; determining whether the second average TEWL value exceeds a second threshold; continuing to implement the first intervention if the second average TEWL value does not exceed the second threshold; continuing to obtain multiple TEWL measurements at the first predetermined frequency if the second average TEWL value does not exceed the second threshold; implementing a second intervention at level M (M is an integer greater than N) if the second average TEWL value exceeds the second threshold; and obtaining multiple TEWL measurements at the second predetermined frequency corresponding to level M if the second average TEWL value exceeds the second threshold.

[0022] In one aspect, the method further includes determining whether the second average TEWL value is less than a third threshold; continuing to implement the first intervention if the second average TEWL value is greater than or equal to the third threshold; continuing to obtain multiple TEWL measurements at a first predetermined frequency if the second average TEWL value is greater than or equal to the third threshold; implementing a third intervention at level L (L is an integer less than N) if the second average TEWL value is less than the third threshold and the first intervention is not level 0; and obtaining multiple TEWL measurements at a predetermined frequency corresponding to level L if the second average TEWL value is less than the third threshold.

[0023] In one aspect, the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0024] In one aspect, the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0025] In one aspect, the Level L third intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0026] In one embodiment, the first average TEWL value is determined from a subset of the first plurality of TEWL measurements, hi one embodiment, the second average TEWL value is determined from a subset of the second plurality of TEWL measurements.

[0027] In one embodiment, the second threshold is equal to the first threshold, hi one embodiment, the third threshold is equal to the first threshold.

[0028] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of pressure ulcer intervention, the method comprising the steps of obtaining multiple TEWL measurements at an anatomical site on the patient; determining an average TEWL value of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); and, if the average TEWL value exceeds the threshold, administering pressure ulcer intervention at the anatomical site; and, if the average TEWL value exceeds the threshold, obtaining multiple TEWL measurements every two hours.

[0029] In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the pressure ulcer intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and low-friction padded mattress surfaces.

[0030] In one aspect, the present disclosure provides and encompasses a method for identifying damaged tissue, the method comprising the steps of obtaining a first TEWL measurement from a first location in tissue beneath a patient's skin, obtaining a second TEWL measurement from a second location bilaterally symmetrical to the first location, determining an average TEWL value for each of the first and second TEWL measurements, determining an average TEWL value from each of the first and second TEWL measurements, determining a difference in the average TEWL values ​​between the first and second TEWL measurements, and determining that tissue damage is present at the first or second location if the difference in the average TEWL values ​​exceeds a threshold.

[0031] In one embodiment, the first location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0032] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining multiple TEWL measurements at a location in tissue beneath the patient's skin at different times; determining an average TEWL value from each of the multiple TEWL measurements; calculating a slope between the most recent average TEWL value and the immediately preceding average TEWL value; comparing the slope to a threshold; and determining that tissue damage is present if the slope exceeds the threshold.

[0033] In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the method is performed at multiple locations.

[0034] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining multiple TEWL measurements at multiple locations on the patient's skin at different times, determining an average TEWL value from each of the multiple TEWL measurements, calculating a TEWL difference between the maximum and minimum average TEWL values ​​for each time period, calculating a derivative of the TEWL difference with respect to time, comparing the derivative to a threshold, and determining that tissue damage is present if the derivative exceeds the threshold.

[0035] In one embodiment, the multiple locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0036] In one embodiment, the derivative with respect to time of the difference value is calculated from the two most recent difference values.

[0037] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining a plurality of TEWL measurements at a location on the patient's skin at each of a plurality of time intervals, determining an average TEWL value from each of the plurality of TEWL measurements, calculating a TEWL difference between the maximum and minimum average TEWL values ​​for each time interval, fitting a curve to a predetermined number of recent TEWL differences, calculating the curvature of the fitted curve, comparing the curvature to a threshold, and determining that tissue damage is present if the curvature exceeds the threshold.

[0038] In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the method is performed at multiple locations.

[0039] Aspects of the present disclosure are described herein, by way of example only, with reference to the accompanying drawings. Referring now in detail to the drawings, it is emphasized that the specific details shown are by way of example and are intended to illustrate aspects of the present disclosure. In this regard, the specification and drawings, considered individually and together, will make apparent to those skilled in the art how aspects of the present disclosure can be practiced. [Brief explanation of the drawings]

[0040] [Figure 1A] Figure 1 shows an example of a currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients using a combination of risk assessment and visual assessment. [Figure 1B] FIG. 1 illustrates an example of a current expanded treatment decision pathway for pressure ulcer prevention currently implemented in some healthcare facilities. [Figure 2] 1 is an exemplary flowchart of a method in which a device for assessing pressure characteristics of tissue beneath a patient's skin may be used in a stand-alone process for preventing pressure sores according to the present disclosure. [Figure 3]1C is an exemplary flowchart of a method in which a device for assessing pressure characteristics of tissue beneath a patient's skin may be used as an aid to further refine the extended treatment decision pathway of FIG. 1B, in accordance with the present disclosure. [Figure 4A] FIG. 1 illustrates an example of a pair of symmetrical locations on the sacral region according to the present disclosure. [Figure 4B] 1A and 1B are diagrams illustrating an example of a pair of symmetrical locations on the bottom surfaces of both feet according to the present disclosure. [Figure 4C] 1A and 1B are diagrams illustrating an example of a pair of symmetrical locations on the sides and soles of both feet according to the present disclosure. [Figure 5A] FIG. 1 illustrates locations on the left and right feet for TEWL measurements according to the present disclosure. [Figure 5B] FIG. 10 is a plot of TEWL values ​​associated with known relative locations for identifying symmetrical locations in accordance with the present disclosure. [Figure 6] FIG. 1 illustrates an integrated system for measuring, evaluating, storing, and transferring TEWL measurements according to the present disclosure. [Figure 7A] 1 is a diagram showing various pressure points on a patient's body in various positions. [Figure 7B] 1 is a diagram showing various pressure points on a patient's body in various positions. [Figure 7C] 1 is a diagram showing various pressure points on a patient's body in various positions. [Figure 7D] 1 is a diagram showing various pressure points on a patient's body in various positions. DETAILED DESCRIPTION OF THE INVENTION

[0041] This specification is not intended to be a detailed catalog of all the different ways in which the present disclosure may be implemented or all the features that may be added to the present disclosure. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, or features illustrated with respect to a particular embodiment may be deleted from that embodiment. Accordingly, the present disclosure contemplates that, in some of its embodiments, any feature or combination of features illustrated herein may be excluded or omitted. Also, numerous modifications and additions to the various embodiments proposed herein will become apparent to those skilled in the art in light of this disclosure without departing from the present disclosure. In other instances, well-known structures, interfaces, and processes have not been shown in detail so as not to unnecessarily obscure the present invention. It is intended that no portion of this specification be construed as denying any portion of the full scope of the present invention. Accordingly, the following description is intended to describe some specific embodiments of the present disclosure, but is not intended to exhaustively specify all permutations, combinations, and variations thereof.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used herein of the present disclosure is for the purpose of describing particular aspects or embodiments only and is not intended to be limiting of the disclosure.

[0043] All publications, patent applications, patents, and other references cited herein are incorporated by reference in their entirety for the teachings relevant to the sentence and / or paragraph in which the reference is presented. References to technology employed herein are intended to represent the technology as commonly understood in the art, including variations on or substitutions of equivalent technologies that will be apparent to those skilled in the art.

[0044] Unless the context clearly indicates otherwise, it is expressly intended that the various features of the present disclosure described herein may be used in any combination. Furthermore, the present disclosure contemplates that in some embodiments thereof, any feature or combination of features set forth herein may be excluded or omitted.

[0045] The methods disclosed herein include and cover one or more steps or actions for achieving the described method. These method steps and / or actions may be interchanged with one another without departing from the scope of the present disclosure. In other words, where a specific order of steps or actions is not required for the proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the present disclosure.

[0046] As used in the specification of this disclosure and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.

[0047] As used herein, "and / or" denotes and covers all possible combinations of one or more of the associated listed items, as well as the exclusion of combinations when interpreted as alternatives ("or").

[0048] As used herein, the terms "about" and "approximately" when describing a measurable value such as a length, frequency, or measurement, are intended to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.5%, or ±0.1% of the stated value.

[0049] As used herein, expressions such as "between X and Y" and "between about X and Y" shall be interpreted to include X and Y. As used herein, expressions such as "between about X and Y" mean "between about X and about Y," and expressions such as "from about X to Y" mean "from about X to about Y."

[0050] As used herein, the term "exemplary" is used to mean serving as an example, instance, or illustration. Any embodiment or aspect described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments or aspects, nor is it intended to exclude equivalent structures and techniques known to those skilled in the art. Rather, use of the term exemplary is intended to present concepts in a concrete manner, and the disclosed subject matter is not limited by such examples.

[0051] As used herein, the term "patient" includes both human and animal subjects.

[0052] As used herein, the term "skin" refers to the surface of a patient's body.

[0053] As used herein, the term "tissue" refers to a collection of similar cells of the same origin and their respective extracellular matrices that together perform a specific function. In some embodiments, the tissue comprises multiple layers of a patient's body, beginning with the stratum corneum and including additional deeper structures such as the epidermis, dermis, and portions of the deeper tissues that contain blood vessels. In one embodiment, the tissue does not comprise the stratum corneum.

[0054] As used herein, the term "wound" refers to damaged or injured tissue, which may or may not be visible on the surface of the skin. A wound may be open or closed. A wound may be caused by surgery. A wound may be a burn. In one embodiment, the wound is a pressure ulcer. In another embodiment, the pressure ulcer is subcutaneous. In one embodiment, the pressure ulcer is a result of prolonged use of a medical device, such as a mask, tubing, or strap. In one embodiment, the wound is a diabetic foot ulcer. In one embodiment, the wound is a vascular ulcer.

[0055] As used herein, "tissue biocapacitance" refers to a biophysical marker that detects early tissue damage based on an increase in the level of fluid accumulated in the interstitial space. Without being bound by theory, the greater the fluid content in the tissue, the higher the biocapacitance value. In some embodiments, the methods described herein comprise measuring tissue biocapacitance. In some embodiments, the methods described herein comprise measuring skin biocapacitance.

[0056] As used herein, the term "time delta" refers to the difference calculated between two values ​​derived from measurements obtained from a subject at different times. In one embodiment, each of the two values ​​is an average calculated from measurements obtained at approximately the same time. In one embodiment, each of the two values ​​is a sum calculated from measurements obtained at approximately the same time. In one embodiment, the two measurements are obtained at approximately the same time (approximately 10 hours or less, approximately 8 hours or less, approximately 6 hours or less, approximately 5 hours or less, approximately 4 hours or less, approximately 3 hours or less, approximately 2 hours or less, or approximately 1 hour or less apart).

[0057] As used herein, the variables "K", "L", "M", and "N" are non-negative integers.

[0058] As used herein, the term "anatomy-specific" refers to the application of a clinical intervention to the same location where a particular TEWL measurement was obtained.

[0059] As used herein, a "system" may be a group of devices in wired or wireless communication with each other.

[0060] As used herein, "bisymmetric" refers to a pair of locations that are approximately equidistant from a line of symmetry.

[0061] As used herein, the term "transepidermal water loss" or "TEWL" refers to the amount of water lost from the body by diffusion across the stratum corneum and provides an assessment of the skin's barrier function. Without being bound by theory, the presence of damaged tissue or a pressure ulcer at an area can result in an alteration in TEWL at or around that area. In one embodiment, a high TEWL value indicates an impairment of the skin's barrier function.

[0062] As used herein, the term "TEWL measurement device" includes any device that captures information about transepidermal water loss at one or more points distributed over a two-dimensional area. In one embodiment, the TEWL measurement device measures the amount of condensed water that diffuses to the skin surface across a certain area of ​​the stratum corneum per unit time. In one embodiment, the TEWL measurement device includes a probe with a sensor. In one embodiment, the TEWL measuring device measures changes in water vapor density. In one embodiment, the TEWL measuring device is an open chamber type device. In one embodiment, the TEWL measuring device is a non-ventilated chamber type device. In one embodiment, the TEWL measuring device is a condensation chamber type device. In one embodiment, the TEWL measuring device is placed in contact with the skin surface during measurement.

[0063] As used herein, the term "light" refers to electromagnetic energy having a wavelength in the range of 1 picometer to 1 meter. In one embodiment, this range is 1 nanometer to 1 millimeter and includes "ultraviolet," "visible," and "infrared" light. In one embodiment, this range is 10 to 390 nanometers, commonly understood as "ultraviolet" light. In one embodiment, this range is 390 to 700 nanometers, commonly understood as "visible" light. In one embodiment, this range is 700 nanometers to 1 millimeter, commonly understood as "infrared" radiation. In one embodiment, this range is 700 to 900 nanometers, commonly understood as "near-infrared" radiation. In one embodiment, the light may be a narrow band of wavelengths, with respect to a particular wavelength. In one embodiment, the particular wavelength is 760 and / or 830 nanometers.

[0064] As used herein, wavelengths and frequencies of light are uniquely related, so that identifying light as having a particular wavelength is equivalent to identifying that light as having a particular frequency, and references to frequencies of light are considered equivalent and interchangeable with references to wavelengths of the same light.

[0065] As used herein, the term "method" includes a sequence of operations (e.g., steps). In certain embodiments, the steps must be performed in a particular order, while in other embodiments, the sequence of operations may be interchanged. "Method" is considered equivalent to and interchangeable with "process." In certain embodiments, one or more disclosed steps are omitted.

[0066] How to evaluate TEWL measurement results In one aspect, the present disclosure provides a method for evaluating TEWL measurements in tissue beneath intact skin of a patient, the method comprising obtaining a TEWL measurement scan on the patient's skin and generating a TEWL measurement map.

[0067] In one embodiment, the TEWL measurement scan includes obtaining a TEWL measurement at a single location on the patient's skin. In one embodiment, the TEWL measurement scan includes obtaining a TEWL measurement at multiple locations on the patient's skin. In one embodiment, the TEWL measurement scan includes obtaining multiple TEWL measurements at multiple locations on the patient's skin. In one embodiment, evaluating the patient includes determining an average TEWL value of the TEWL measurements. In one embodiment, evaluating the patient includes determining an average TEWL value of a plurality of TEWL measurements. In one embodiment, the TEWL measurement map represents a map of pressure applied to the skin.

[0068] In one embodiment, the mean TEWL value at a location is determined from two, three, four, five, six, seven, eight, nine, ten, or more TEWL values ​​measured at that location. In one embodiment, the TEWL difference is determined by the difference in mean TEWL values ​​from measurements taken at two symmetrical locations about the centerline.

[0069] In one embodiment, a TEWL value may be calculated from multiple TEWL measurements made at a specific location or in close proximity to a specific location in the methods disclosed herein. In one embodiment, multiple TEWL measurements are made in a predetermined pattern on the skin, and a TEWL value is calculated by subtracting a TEWL value associated with a specific location in the pattern from a maximum TEWL value made at other locations in the pattern. In one embodiment, multiple TEWL measurements are made in a predetermined pattern on the skin, and a TEWL value is calculated by identifying a TEWL value associated with a specific location in the pattern and subtracting the maximum TEWL value made at other locations in the pattern. In one embodiment, a TEWL value may be calculated from a portion of a set of TEWL values ​​generated by multiple TEWL measurements at a single location, and a TEWL value calculated as the maximum difference between the average value of the same set and a single TEWL value. In one embodiment, a TEWL value may be calculated as the ratio of the maximum TEWL value to the minimum TEWL value in the set of TEWL values.

[0070] In one embodiment, the method provided herein is based on the TEWL value measured in the tissue under the patient's skin. In one embodiment, the method provided herein is applied from the time the patient is admitted to a healthcare facility until the patient is discharged from the healthcare facility.

[0071] In one embodiment, the wound is a pressure ulcer. In one embodiment, the pressure ulcer is a pressure ulcer resulting from prolonged use of a medical device, such as a mask, tubing, or strap. In one embodiment, the wound is a diabetic foot ulcer. In one embodiment, the wound is a vascular ulcer. In one embodiment, the wound is a burn.

[0072] Methods for reducing the incidence of tissue damage In one aspect, the disclosure provides and encompasses a method of reducing the incidence of tissue injury in patients admitted to a healthcare facility, the method comprising: assessing the patient for risk of tissue injury upon admission to the healthcare facility, the step comprising obtaining TEWL measurements of the patient at one or more body locations at risk for wound development and determining an average TEWL value of the TEWL measurements; and implementing a Level 0 intervention if the average TEWL value is below a first threshold; and implementing a Level N intervention if the average TEWL value exceeds the first threshold, where N is an integer equal to or greater than 1. In one aspect, the incidence of ulcers in healthcare facility patients is reduced to less than 1 in 100, less than 1 in 200, less than 1 in 300, less than 1 in 400, less than 1 in 500, less than 1 in 600, less than 1 in 700, less than 1 in 800, less than 1 in 900, or less than 1 in 1000.

[0073] In one embodiment, the healthcare facility is selected from the group consisting of a hospital, a recovery facility, an assisted living facility, a home health care facility, a nursing home, a long-term care facility, a continuing care community, and an independent living community. In one embodiment, the healthcare facility may be the patient's home or other residence, in which case the "admission" step is an initial assessment in the patient's home by a nurse or other caregiver. In one embodiment, the schedule of interventions and assessment intervals used in the home environment may differ from the corresponding interventions and intervals used in the hospital.

[0074] In one embodiment, the methods disclosed herein include assessing a newly admitted patient for risk of tissue damage. In one embodiment, assessing the patient includes performing a visual assessment. In one embodiment, the visual assessment is performed according to guidance from the National Pressure Ulcer Advisory Panel (NPUAP).

[0075] In one embodiment, evaluating the patient includes performing a risk assessment. In one embodiment, the risk assessment is performed according to a test selected from the group consisting of the Braden Scale, the Gosnell Scale, the Norton Scale, and the Waterlow Scale. In one embodiment, evaluating the patient further includes performing an assessment using one or more objective measurements selected from the group consisting of subepidermal water, bioimpedance, blood perfusion, biocapacitance, blood oxygenation, spectral imaging, PET imaging, capillary pressure, magnetic resonance imaging, infrared imaging, ultrasound imaging, pressure, and detecting the presence of interleukin-1 alpha at one or more anatomical sites of interest.

[0076] 7A-7D illustrate, with circles, various locations of a patient's tissue injury risk. In one embodiment, the one or more body locations at risk for developing pressure injury are selected from the group consisting of the back of the head, shoulders, base of the spine, buttocks, heels, feet, elbows, ears, lower back, thighs, legs, rib cage, and knees. In one embodiment, the one or more body locations at risk for developing tissue injury are selected from the group consisting of the sternum, sacrum, heels, os latum scapularum, elbows, ears, and other fleshy tissues over bony prominences of a patient.

[0077] In one embodiment, a newly admitted patient undergoes an intake assessment including one or more of visual inspection of a portion of the patient's skin, completion of at least a portion of a risk assessment protocol evaluating one or more of nutrition, exercise, physical activity, strength, and communication ability, and TEWL measurements are obtained at one or more locations on the patient's skin. In one embodiment, the TEWL measurement scan involves obtaining multiple TEWL measurements at a single "location" on the patient's skin. In one embodiment, a "location" is considered an area rather than a single point, so that TEWL measurements can be made at spatially separated points within the location. For example, the heel location includes the inner, outer, and posterior surfaces around the heel, as well as the posterior part of the plantar surface of the foot. In one embodiment, the TEWL measurement scan involves obtaining TEWL measurements at a single location on the patient's skin. In one embodiment, the TEWL measurement scan involves obtaining TEWL measurements at multiple locations on the patient's skin. In one embodiment, the TEWL measurement scan involves obtaining multiple TEWL measurements at multiple locations on the patient's skin. In one embodiment, evaluating the patient includes determining an average TEWL value of the TEWL measurements. In one embodiment, evaluating the patient includes determining a mean TEWL value of multiple TEWL measurements.

[0078] How to assign patients to risk categories In one aspect, once the assessment steps are completed, a determination is made as to whether the patient's measurements are abnormal, i.e., whether the combined results of the various elements of the assessment indicate that the patient has or is at risk for developing additional wound tissue damage. Each element of the assessment may have individual criteria for the level of risk (e.g., a scoring system with thresholds indicating unacceptable risk).

[0079] In one embodiment, if the mean TEWL value is less than or equal to the first threshold, a Level 0 intervention is implemented. In one embodiment, if the mean TEWL value is greater than the first threshold, a Level N intervention is implemented. In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art may select a predetermined value. In one embodiment, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body on which the measurement is being performed, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0080] In one embodiment, a mean TEWL value above a first threshold is indicative of a patient at risk for developing a pressure sore or tissue damage.

[0081] In one embodiment, if the patient is determined to be at an acceptable risk level, a minimum level of intervention, designated herein as "Level Zero" or "Level 0," will be implemented, and the patient will be re-evaluated using at least the TEWL measurement protocol at the frequency (or conversely, time interval) associated with Level 0. In one embodiment, if the mean TEWL value falls below the threshold, a Level 0 intervention will be implemented.

[0082] In one embodiment, if the patient is determined to have an abnormal measurement, a higher level of intervention is implemented. In one embodiment, a hierarchy of intervention levels is defined, with each level implementing a more intensive intervention than the level below it. Also, in one embodiment, each level is defined with a monitoring interval or frequency indicating how often a set of TEWL measurements should be made, generally with shorter intervals for higher levels. In one embodiment, the process is defined at this point by the hospital or other governing body to implement the next level of Level 1 intervention. In another embodiment, Level 2 or higher levels of intervention may be implemented. The process now enters a new loop, with the patient being monitored at a frequency of Level N (N ranging from 1 to n, where n is the highest defined level of intervention and monitoring). In one embodiment, if the average TEWL value is above a threshold, Level N intervention is implemented. In one embodiment, Level N intervention is anatomical-specific.

[0083] In one embodiment, TEWL measurements of body locations identified as having possible damage in an initial set of TEWL measurements are obtained at a first time interval. In one embodiment, TEWL measurements of all other body locations selected for monitoring are obtained at a second time interval longer than the first time interval. In one embodiment, the values ​​of the first and second time intervals vary depending on the risk category to which the patient is assigned. For example, a high-risk patient may have a first time interval of 4 hours and a second time interval of 1 day, while a low-risk patient may have a first time interval of 1 day and a second time interval of 1 week. In one embodiment, the time intervals may be event-based (e.g., based on staff or shift changes) rather than strictly time-based. Generally, body locations with high TEWL values ​​are scanned more frequently than other body locations being monitored that have normal TEWL values ​​in previous TEWL measurement sessions.

[0084] In one embodiment, the intervals at which TEWL measurements are obtained are determined by the TEWL values ​​from the previous TEWL measurement session. For example, for a body site whose TEWL value in the previous measurement session was equal to or greater than a first threshold, TEWL measurements are performed at a first time interval, while for a body site whose previous TEWL value was equal to or greater than a second threshold that is higher than the first threshold, TEWL measurements are performed at a second time interval that is shorter than the first time interval.

[0085] How to assign patients to risk categories In one aspect, the present disclosure provides and encompasses a method for assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, the method including the steps of obtaining a plurality of initial TEWL measurements of the patient at one or more body locations selected for monitoring, determining an average TEWL value of the TEWL measurements, and assigning the patient to a risk category selected from the plurality of risk categories based in part on the average TEWL value of the TEWL measurements.

[0086] In one embodiment, a patient's risk level is determined entirely by TEWL measurements. In one embodiment, a patient's risk level is determined entirely by visual examination of the patient. In one embodiment, a patient's risk level is determined entirely by administering a risk assessment protocol to the patient. In one embodiment, a patient's risk level is determined by measuring TEWL and visual examination of the patient. In one embodiment, a patient's risk level is determined by administering a risk assessment protocol to the patient and visual examination of the patient. In one embodiment, a patient's risk level is determined by measuring TEWL and administering a risk assessment protocol to the patient. In one embodiment, a patient's risk level is determined by measuring TEWL, administering a risk assessment protocol to the patient, and visually inspecting the patient. In one embodiment, a protocol exists in which a combination of criteria generates a composite parameter that can be used to select a level of intervention.

[0087] In one embodiment, a patient is assigned to one risk category selected from a plurality of risk categories. In one embodiment, the risk categories include a high-risk category and a high-risk category. In one embodiment, the risk categories include a low-risk category and a high-risk category. In one embodiment, the risk categories include a low-risk category, a high-risk category, and a high-risk category. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 risk categories. In one embodiment, the risk categories are associated with corresponding levels of medical care. In one embodiment, the risk categories are associated with corresponding levels of intervention. In one embodiment, the risk categories are associated with corresponding frequencies of subsequent TEWL measurements.

[0088] In one embodiment, patients are assigned to risk categories based on average TEWL values. In one embodiment, patients are assigned to risk categories based on absolute average TEWL values. In one embodiment, patients are assigned to risk categories by comparison of average TEWL values ​​to a threshold value. In one embodiment, patients are assigned to risk categories by comparison of average TEWL values ​​to maximum intensity values. In one embodiment, assignment is based solely on the initial maximum TEWL value found during the initial TEWL measurement scan.

[0089] Methods for assigning patients to levels of care and intervention In one aspect, the present disclosure provides and encompasses a method for stratifying a plurality of patients in a healthcare facility based on level of healthcare care, the method including the steps of obtaining TEWL measurements of one patient of the plurality of patients at one or more body locations selected for monitoring, determining an average TEWL value of the TEWL measurements of the patient, determining a healthcare level among N levels of healthcare care that corresponds to the average TEWL value, assigning a healthcare level to the patient, and placing the patient of the plurality of patients into groups based on each of the levels of healthcare care assigned to the patient.

[0090] In one embodiment, a patient is assigned to a level of care based on the average TEWL value. In one embodiment, a patient is assigned to a level of care corresponding to the average TEWL value out of N levels of care. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 levels of care. In one embodiment, each of the N levels of care corresponds to a range of average TEWL values. In one embodiment, a level of care is associated with a corresponding level of intervention. In one embodiment, a level of care is associated with a corresponding frequency of subsequent TEWL measurements. In one embodiment, multiple patients are grouped and arranged according to their assigned level of care. In one embodiment, multiple patients are grouped such that patients within a group are assigned the same level of care. In one embodiment, multiple patients are grouped such that patients within a group are given the same intervention.

[0091] In one aspect, the present disclosure provides a method of identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method comprising obtaining a plurality of TEWL measurements of the patient at one or more body locations; determining an average TEWL value of the patient's TEWL measurements; administering one or more anatomical-specific interventions based on the average TEWL value; increasing the level of the anatomical-specific intervention based on an increase in the average TEWL value; and decreasing the level of the anatomical-specific intervention based on a decrease in the average TEWL value.

[0092] In one embodiment, a patient is assigned to a level of medical care based on the average TEWL value. In one embodiment, a patient is assigned to a level of medical care among N levels of medical care that corresponds to the average TEWL value. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 levels of medical care. In one embodiment, each of the N levels of medical care corresponds to a range of average TEWL values. In one embodiment, a level of medical care is associated with a corresponding level of intervention. In one embodiment, a level of medical care is associated with a corresponding frequency of subsequent TEWL measurements.

[0093] In one embodiment, a patient's history is evaluated to determine whether the patient's condition is improving. If the patient's condition is improving, for example, as evidenced by a decrease in the mean TEWL value, the level of intervention is decreased. In one embodiment, the current level of intervention is continued until the mean TEWL value falls below a threshold value. In one embodiment, if the mean TEWL value is trending downward, the level of intervention may be decreased based on the magnitude of the mean TEWL value. If the patient's condition is worsening, for example, as evidenced by an increase in the mean TEWL value, the level of intervention is increased. In one embodiment, the current level of intervention is continued until the mean TEWL value is above a threshold value. In one embodiment, if the mean TEWL value is trending upward, the level of intervention may be increased based on the magnitude of the mean TEWL value.

[0094] In one embodiment, if the patient does not show improvement, the process branches to an increased level of intervention, assuming the skin has not broken down, i.e., no open wounds have developed. If an open wound has developed, TEWL measurements will be taken around the open wound to map inflammation or other precursors to wound expansion. The open wound itself will be treated, and the perimeter will be monitored until the wound closes.

[0095] In one aspect, the anatomy-specific intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0096] In one embodiment, the decision to implement an intervention for a specific body region or a general intervention, such as a high-performance mattress, is based on the TEWL value found at that region in a TEWL measurement scan. If the TEWL value is below a predetermined threshold, no intervention is required. If the TEWL value is above a predetermined threshold, an intervention is selected and implemented based in part on the body region and the average TEWL value for that region. The predetermined threshold for selecting and implementing an intervention may be higher or lower than the threshold for determining that an injury may exist at that region.

[0097] How to manage medical care In one aspect, the disclosure provides a method of managing the medical care of a patient, the method comprising the steps of obtaining a first set of TEWL measurements at one or more body locations selected for monitoring upon admission to a medical care facility; determining a first average TEWL value for each of the first set of TEWL measurements; if one of the average TEWL values ​​in the first set of TEWL measurements exceeds a first threshold, setting an intervention level N=1; implementing level N of intervention for each of the one or more body locations whose average TEWL value exceeds the first threshold; obtaining subsequent sets of TEWL measurements at each of the one or more body locations at a frequency of level N; and determining a new average TEWL value for each of the one or more body locations.

[0098] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, a predetermined value can be selected by one of skill in the art based on the given units of the TEWL value. In one aspect, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body where the measurement is being taken, or according to one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0099] In one embodiment, N ranges from 1 to 50 (e.g., 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40, or 1 to 45). In one embodiment, N is determined by the amount by which the first average TEWL value exceeds a first threshold. In one embodiment, Level N intervention corresponds to a range of average TEWL values. In one embodiment, Level N intervention is associated with a corresponding anatomical structure-specific intervention. In one embodiment, Level N intervention is associated with a corresponding frequency of subsequent TEWL measurements. In one embodiment, Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid and dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces.

[0100] In one embodiment, the patient's medical care is discharge or transfer from a medical care facility. In one embodiment, the patient's condition upon discharge or transfer is documented. In one embodiment, a final set of TEWL measurements is obtained at one or more locations on the patient's body prior to discharge or transfer. In one embodiment, a final set of TEWL measurements is generated at one or more locations on the patient's body. In one embodiment, these locations are one or more body locations selected for monitoring. In one embodiment, these locations include areas that have not received intervention and areas that have not previously been identified as risk. In one embodiment, this information is provided to the receiving medical caregiver.

[0101] Methods for identifying and treating patients at risk for tissue injury In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient at risk for tissue damage. In one aspect, the method includes the steps of: assessing a patient for risk of tissue damage upon admission to a healthcare facility, the step including obtaining a first plurality of TEWL measurements of the patient and determining a first average TEWL value of the first plurality of TEWL measurements; and implementing a first intervention at Level 0 if the first average TEWL value is less than or equal to a first threshold; and implementing a first intervention at Level N (N is an integer greater than or equal to 1) if the first average TEWL value is greater than the first threshold. In one aspect, the first average TEWL value is determined from a subset of the first plurality of TEWL measurements.

[0102] 7A-7D illustrate, with circles, points of risk of tissue injury for a patient at various locations. In one embodiment, a first plurality of TEWL measurements are taken at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the first plurality of TEWL measurements are taken at and around one or more anatomical sites in chronic contact with the medical device, the anatomical sites being selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the first plurality of TEWL measurements are separated into subgroups for analysis based on the approximate locations at which the measurements are taken. In one embodiment, the average TEWL value is determined from a subset of the first plurality of TEWL measurements. In one embodiment, the first plurality of TEWL measurements are taken at one or more concentric circular locations centered on the anatomical location. In one embodiment, the first plurality of TEWL measurements are taken at linear locations approximately equidistant from the anatomical location.

[0103] In one embodiment, the first TEWL difference is determined by the difference between the maximum and minimum TEWL values ​​from the first plurality of collected TEWL measurements. In one embodiment, the first TEWL difference is determined by the difference between the maximum average TEWL value from measurements taken at one location and the minimum average TEWL value from measurements taken at a second location. In one embodiment, the first TEWL difference is determined by the difference between the maximum average TEWL value from measurements taken at one location and the absolute minimum TEWL value from measurements taken at a second location. In one embodiment, the first TEWL difference is determined by the difference between the absolute maximum TEWL value from measurements taken at one location and the minimum average TEWL value from measurements taken at a second location. In one embodiment, the first TEWL difference is determined by the difference between the maximum average TEWL value from measurements taken at the same location but at different times. In one embodiment, the first TEWL value is determined for a subset of the first plurality of TEWL measurements, each subset comprising a subgroup defined by the location from which the measurements were taken. In one embodiment, the average TEWL value at a location is determined from two, three, four, five, six, seven, eight, nine, ten, or more TEWL values ​​measured at that location. In one embodiment, a first TEWL difference is determined by the difference between average TEWL values ​​from measurements taken at two symmetrical locations about the midline. In one embodiment, the first TEWL difference is the difference between absolute TEWL values ​​from measurements taken at two symmetrical locations about the midline. In one embodiment, the first TEWL difference is the difference between TEWL values ​​measured at a location on the left side of the body (e.g., the left heel) and the same location on the right side of the body (e.g., the right heel).

[0104] In one embodiment, a TEWL value may be calculated from multiple TEWL measurements made at a specific location or in close proximity to a specific location, as in the methods disclosed herein. In one embodiment, multiple TEWL measurements are made in a predetermined pattern on the skin, and a TEWL value is calculated by subtracting a TEWL value associated with a specific location within the pattern from a maximum TEWL value made at other locations within the pattern. In one embodiment, multiple TEWL measurements are made in a predetermined pattern on the skin, and a TEWL value is calculated by identifying a TEWL value associated with a specific location within the pattern and subtracting the maximum TEWL value made at other locations within the pattern. In one embodiment, an average TEWL value may be calculated from a portion of a set of TEWL values ​​generated by multiple TEWL measurements at a single location, and an average TEWL value calculated as the maximum difference between the average value of the same set and a single TEWL value. In one embodiment, an average TEWL value may be calculated as the ratio of the maximum TEWL value to the minimum TEWL value within the set of TEWL values.

[0105] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, a predetermined value can be selected by one of skill in the art based on the given units of the TEWL value. In one aspect, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body where the measurement is being taken, or according to one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0106] In one embodiment, N ranges from 1 to 50 (such as 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40, or 1 to 45).

[0107] In one embodiment, N is determined by the amount by which the first average TEWL value exceeds a first threshold. In one embodiment, the amount by which the threshold established for (N+1) exceeds the first threshold is greater than the amount by which the threshold established for N exceeds the first threshold. In one embodiment, the amount by which the threshold established for (N-1) exceeds the first threshold is less than the amount by which the threshold established for N exceeds the first threshold. In one embodiment, the threshold established for (N+1) is greater than the threshold established for N. In one embodiment, the threshold established for N is greater than the threshold established for (N-1).

[0108] Choosing the level of intervention In one embodiment, Level 1 (N=1) intervention is applied to patients whose mean TEWL values ​​above the threshold are 100% or less of the threshold (such as 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, Level 1 intervention is applied where measurements were taken.

[0109] In one embodiment, Level 2 (N=2) intervention is applied to patients with mean TEWL values ​​above the threshold that are 150% or less of the threshold (such as 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, Level 2 intervention is applied where measurements were taken.

[0110] In one embodiment, Level 3 (N=3) intervention is administered to patients with mean TEWL values ​​above the threshold that are 200% or less of the threshold (such as 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, a level 3 intervention is applied where the measurement was taken.

[0111] In one embodiment, the average TEWL value above the threshold is 250% or less of the threshold (245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 15 ... Level 4 (N=4) intervention is applied to patients with a mean saturation of 35% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, Level 4 intervention is applied where measurements were taken.

[0112] In one embodiment, the average TEWL value above the threshold is 300% or less of the threshold (295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 18 ... Level 5 (N=5) intervention is applied to patients with a mean HR of 60% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, Level 5 intervention is applied to patients where measurements were taken.

[0113] In one embodiment, the average TEWL value above the threshold is 350% or less of the threshold (345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 19 ... Level 6 (N=6) intervention is applied to patients with a mean (e.g., 85% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, Level 6 intervention is applied to patients where measurements were taken.

[0114] In one embodiment, the average TEWL value above the threshold is 400% or less of the threshold (395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215 ... Level 7 (N=7) interventions were applied to patients with a mean HR of 10% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less. In one embodiment, a level 7 intervention is applied where the measurement was taken.

[0115] In one embodiment, the average TEWL value above the threshold is 450% or less of the threshold (445% or less, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less of the threshold). Below, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 29 5% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 2 35% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less , 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less Level 8 (N=8) intervention is applied to patients with a mean (e.g., below 115%, below 110%, below 100%, below 95%, below 90%, below 85%, below 80%, below 75%, below 70%, below 65%, below 60%, below 55%, below 50%, below 45%, below 40%, below 35%, below 30%, below 25%, below 20%, below 15%, below 10%, or below 5%. In one embodiment, Level 8 intervention is applied where measurements were taken.

[0116] In one embodiment, the average TEWL value above the threshold is 500% or less of the threshold (495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less of the threshold, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 2 60% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 1 95% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 1 Level 9 (N=9) intervention is applied to patients with a mean saturation of 30% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, Level 9 intervention is applied where measurements were taken.

[0117] In one embodiment, the average TEWL value above the threshold is 550% or less of the threshold (545% or less, 540% or less, 535% or less, 530% or less, 525% or less, 520% ​​or less, 515% or less, 510% or less, 505% or less, 500% or less, 495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less, 435% or less, 430% or less of the threshold). Below, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less , 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 28 5% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% Below, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less Level 10 (N=10) intervention is administered to patients with a mean (e.g., 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, Level 10 intervention is administered to patients where measurements were taken.

[0118] In one embodiment, level N intervention is stronger than level 0 intervention. In one embodiment, level (N+1) intervention is stronger than level N intervention. In one embodiment, level (N-1) intervention is weaker than level N intervention.

[0119] Methods for identifying and treating patients at risk for tissue damage (subsequent imaging) In one aspect, the present disclosure further provides and encompasses the steps of obtaining a second plurality of TEWL measurements of the patient at a first predetermined frequency corresponding to the level of intervention implemented; determining a second average TEWL value from the second plurality of TEWL measurements; determining whether the second average TEWL value exceeds a second threshold; continuing to implement the first intervention if the second average TEWL value does not exceed the second threshold; continuing to obtain multiple TEWL measurements at the first predetermined frequency if the second average TEWL value does not exceed the second threshold; implementing a second intervention at level M (M is an integer greater than N) if the second average TEWL value exceeds the second threshold; and obtaining multiple TEWL measurements at the second predetermined frequency corresponding to level M if the second average TEWL value exceeds the second threshold.

[0120] In one embodiment, the predetermined frequency is selected from the group consisting of at least once every 72 hours, at least once every 48 hours, at least once every 24 hours, at least once every 12 hours, at least once every 8 hours, at least once every 6 hours, at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, and at least once every half hour.

[0121] In one embodiment, the second plurality of TEWL measurements are taken at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on a patient's bony prominences. In one embodiment, the second plurality of TEWL measurements are taken at and around one or more anatomical locations that are in chronic contact with the medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the second plurality of TEWL measurements are separated into subgroups for analysis based on the approximate locations at which the measurements are taken. In one embodiment, a second average TEWL value is determined from a subset of the second plurality of TEWL measurements. In one embodiment, the second plurality of TEWL measurements are taken at locations on one or more concentric circles centered on the anatomical location. In one embodiment, the second plurality of TEWL measurements are taken at locations on a line approximately equidistant from the anatomical location.

[0122] In one embodiment, the second TEWL difference is determined by the difference between the maximum and minimum TEWL values ​​from the collected second plurality of TEWL measurements. In one embodiment, the second TEWL difference is determined by the difference between the maximum average TEWL value of measurements taken at a location and the minimum TEWL value of measurements taken at a second location. In one embodiment, the second TEWL difference is determined by the difference between the maximum average TEWL value of measurements taken at the same location and the minimum TEWL value of measurements taken at the same location. In one embodiment, the second average TEWL value is determined for a subset of the second plurality of TEWL measurements, each comprising a subgroup defined by the location at which the measurements were taken. In one embodiment, the second average TEWL value at a location is determined from two, three, four, five, six, seven, eight, nine, ten, or more TEWL values ​​measured at that location. In one embodiment, the second TEWL difference is determined by the difference between the average TEWL values ​​from measurements taken at two symmetrical locations about the centerline. In one embodiment, the second plurality of TEWL measurements are made at the same location as the first plurality of TEWL measurements. In one embodiment, the second plurality of TEWL measurements are made at some of the same locations as the first plurality of TEWL measurements. In one embodiment, the second plurality of TEWL measurements are made near the locations where the first plurality of TEWL measurements were made. In one embodiment, the second plurality of TEWL measurements are made at a different location than the first plurality of TEWL measurements.

[0123] In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the second threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the second threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold may be greater than the first threshold. In one embodiment, the second threshold may be less than the first threshold.

[0124] In one aspect, the second average TEWL value is 0.1 to 99.5% of the second threshold (0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 35%, 2 Possible values ​​include 5-50%, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70-80%, 75%-85%, 80-90%, 85-95%, 90-99.5%, 65-85%, or 75-99.5%.

[0125] In one embodiment, M ranges from 2 to 50 (such as 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40, or 2 to 45).

[0126] In one embodiment, M is determined by the amount by which the second TEWL value exceeds the second threshold. In one embodiment, the amount by which the threshold established for (M+1) exceeds the second threshold is greater than the amount by which the threshold established for M exceeds the second threshold. In one embodiment, the amount by which the threshold established for (M-1) exceeds the second threshold is less than the amount by which the threshold established for M exceeds the second threshold. In one embodiment, the threshold established for (M+1) is greater than the threshold established for M. In one embodiment, the threshold established for M is greater than the threshold established for (M-1).

[0127] In one embodiment, level M of intervention is selected according to the above "Selecting Level of Intervention" section of this disclosure, substituting M for N.

[0128] In one aspect, the present disclosure further provides and encompasses the steps of determining whether the second average TEWL value is less than a third threshold; continuing to implement the first intervention if the second average TEWL value is greater than or equal to the third threshold; continuing to obtain multiple TEWL measurements at a first predetermined frequency if the second average TEWL value is greater than or equal to the third threshold; implementing a third intervention at level L (L is an integer less than N) if the second average TEWL value is less than the third threshold and the first intervention is not level 0; and obtaining multiple TEWL measurements at a predetermined frequency corresponding to level L if the second average TEWL value is less than the third threshold.

[0129] In one embodiment, L ranges from 0 to 50 (such as 0 to 3, 0 to 4, 0 to 5, 0 to 6, 0 to 7, 0 to 8, 0 to 9, 0 to 10, 0 to 15, 0 to 20, 0 to 25, 0 to 30, 0 to 35, 0 to 40, or 0 to 45).

[0130] In one embodiment, L is determined by the amount by which the second average TEWL value falls below a third threshold. In one embodiment, the amount by which the threshold established for (L-1) falls below the third threshold is greater than the amount by which the threshold established for L falls below the third threshold. In one embodiment, the amount by which the threshold established for (L+1) falls below the third threshold is less than the amount by which the threshold established for L falls below the third threshold. In one embodiment, the threshold established for (L+1) is greater than the threshold established for L. In one embodiment, the threshold established for L is greater than the threshold established for (L-1).

[0131] In one embodiment, the third threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the third threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the third threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the third threshold is equal to the first threshold. In one embodiment, the third threshold may be greater than the first threshold. In one embodiment, the third threshold may be less than the first threshold. In one embodiment, the third threshold is equal to the second threshold, in one embodiment, the third threshold can be greater than the second threshold, or in one embodiment, the third threshold can be less than the second threshold.

[0132] In one aspect, the second average TEWL value is 0.1 to 99.5% of the third threshold (0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 35%, 2 Possible values ​​include 5-50%, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70-80%, 75%-85%, 80-90%, 85-95%, 90-99.5%, 65-85%, or 75-99.5%.

[0133] In one embodiment, level L of intervention is selected according to the above "Selection of Intervention Level" of this disclosure, substituting L for N.

[0134] In one embodiment, Level N interventions are selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces. In one embodiment, Level M interventions are selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces. In one embodiment, Level L interventions are selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces.

[0135] Methods for slowing the progression of skin and tissue damage In one aspect, the present disclosure provides and encompasses a method for slowing the progression of skin and tissue damage in a patient in need thereof, comprising the steps of identifying a current level K intervention for the patient; obtaining a plurality of TEWL measurements for the patient; calculating an average TEWL value from a portion of the plurality of TEWL measurements; determining whether the average TEWL value exceeds a first threshold; continuing to administer the current intervention if the average TEWL value does not exceed the first threshold; continuing to obtain a plurality of TEWL measurements at a predetermined frequency corresponding to level K if the average TEWL value does exceed the first threshold; implementing a new level N intervention (N greater than K) if the average TEWL value exceeds the first threshold; and obtaining a plurality of TEWL measurements at a predetermined frequency corresponding to level N if the average TEWL value exceeds the first threshold.

[0136] In one embodiment, the patient in need is a patient experiencing a change in medical care, a change in mobility, a change in nutrition, a change in sensation, or a combination thereof. In one embodiment, the patient in need is a patient who has developed an open wound. In one embodiment, the patient in need is a patient who has healed from an open wound. In one embodiment, the patient in need is a patient who is undergoing surgery. In one embodiment, the patient in need is a patient recovering from surgery. In one embodiment, the patient in need is a patient receiving spinal or sacral analgesia during surgery. In one embodiment, the patient in need is a patient undergoing surgery for a duration of 4 hours or more (e.g., 5 hours or more, 6 hours or more, 7 hours or more, 8 hours or more, 9 hours or more, 10 hours or more, 11 hours or more, or 12 hours or more). In one embodiment, the duration of the surgery is 1 hour or more (e.g., 2 hours or more or 3 hours or more).

[0137] In one embodiment, the multiple TEWL measurements are taken at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on a patient's bony prominences. In one embodiment, the multiple TEWL measurements are taken at and around one or more anatomical locations that are in chronic contact with a medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the multiple TEWL measurements are separated into subgroups for analysis based on the approximate locations at which the measurements are taken. In one embodiment, an average TEWL value is determined from a subset of the multiple TEWL measurements. In one embodiment, the multiple TEWL measurements are taken at locations on one or more concentric circles centered on the anatomical location. In one embodiment, the multiple TEWL measurements are taken at locations on a line approximately equidistant from the anatomical location.

[0138] In one embodiment, an average TEWL value may be calculated from multiple TEWL measurements made at a specific location or in close proximity to a specific location in the methods disclosed herein. In one embodiment, multiple TEWL measurements are made in a predetermined pattern on the skin, and the average TEWL value is calculated by subtracting the TEWL value associated with a specific location in the pattern from the maximum TEWL value made at other locations in the pattern. In one embodiment, multiple TEWL measurements are made in a predetermined pattern on the skin, and the average TEWL value is calculated by identifying the TEWL value associated with a specific location in the pattern and subtracting the maximum TEWL value made at other locations in the pattern. In one embodiment, an average TEWL value may be calculated from a portion of a set of TEWL values ​​generated by multiple TEWL measurements at a single location, and the average TEWL value calculated as the maximum difference between the average value of the same set and a single TEWL value. In one embodiment, an average TEWL value may be calculated as the ratio of the maximum TEWL value to the minimum TEWL value in the set of TEWL values.

[0139] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold may be scaled by a factor or multiple based on the values ​​given herein.

[0140] In one embodiment, K ranges from 2 to 50 (such as 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40, or 2 to 45).

[0141] In one embodiment, K is determined by the amount by which the average TEWL value exceeds a threshold value. In one embodiment, the amount by which the average TEWL value exceeds a threshold value defined for (K+1) is greater than the amount by which the average TEWL value exceeds a threshold value defined for K. In one embodiment, the amount by which the average TEWL value exceeds a threshold value defined for (K-1) is less than the amount by which the average TEWL value exceeds a threshold value defined for K.

[0142] In one embodiment, level K intervention is selected according to the above "Selection of Intervention Level" of this disclosure, substituting K for N.

[0143] In one aspect, the present disclosure further provides and encompasses the steps of determining whether the average TEWL value is less than a second threshold, and if the average TEWL value is less than the second threshold, implementing an intervention at level L (L is a non-negative value less than K), and if the average TEWL value is less than the second threshold, making multiple TEWL measurements at a predetermined frequency corresponding to level L.

[0144] In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the second threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the second threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold may be greater than the first threshold. In one embodiment, the second threshold may be less than the first threshold.

[0145] In one embodiment, L can be K-1, K-2, K-3, K-4, K-5, K-6, K-7, K-8, K-9, or K-10. In one embodiment, when the average TEWL value is 90 to 99.5% of the second threshold (e.g., 90 to 95%, 91 to 96%, 92 to 97%, 93 to 98%, 94 to 99%, or 95 to 99.5% of the second threshold), L is K-1, except when K-1 is less than 0 (in which case L is 0). In one embodiment, when the average TEWL value is 80 to 89.9% of the second threshold (e.g., 80 to 85%, 81 to 86%, 82 to 87%, 83 to 88%, 84 to 89%, or 85 to 89.9% of the second threshold), L is K-2, except when K-2 is less than 0 (in which case, L is 0). In one embodiment, when the average TEWL value is 70 to 79.9% of the second threshold (e.g., 70 to 75%, 71 to 76%, 72 to 77%, 73 to 78%, 74 to 79%, or 75 to 79.9% of the second threshold), L is K-3, except when K-3 is less than 0 (in which case, L is 0). In one embodiment, when the average TEWL value is 60 to 69.9% of the second threshold (e.g., 60 to 65%, 61 to 66%, 62 to 67%, 63 to 68%, 64 to 69%, or 65 to 69.9% of the second threshold), L is K-4, except when K-4 is less than 0 (in which case L is 0). In one embodiment, when the average TEWL value is 50 to 59.9% of the second threshold (e.g., 50 to 55%, 51 to 56%, 52 to 57%, 53 to 58%, 54 to 59%, or 55 to 59.9% of the second threshold), L is K-5, except when K-5 is less than 0 (in which case L is 0). In one embodiment, when the average TEWL value is 40 to 49.9% of the second threshold (e.g., 40 to 45%, 41 to 46%, 42 to 47%, 43 to 48%, 44 to 49%, or 45 to 49.9% of the second threshold), L is K-6, except when K-6 is less than 0 (in which case L is 0). In one embodiment, when the average TEWL value is 30 to 39.9% of the second threshold (e.g., 30 to 35%, 31 to 36%, 32 to 37%, 33 to 38%, 34 to 39%, or 35 to 39.9% of the second threshold), L is K-7, except when K-7 is less than 0 (in which case L is 0).In one embodiment, when the average TEWL value is 20 to 29.9% of the second threshold (e.g., 20 to 25%, 21 to 26%, 22 to 27%, 23 to 28%, 24 to 29%, or 25 to 29.9% of the second threshold), L is K-8, except when K-8 is less than 0 (in which case L is 0). In one embodiment, when the average TEWL value is 10 to 19.9% ​​of the second threshold (e.g., 10 to 15%, 11 to 16%, 12 to 17%, 13 to 18%, 14 to 19%, or 15 to 19.9% ​​of the second threshold), L is K-9, except when K-9 is less than 0 (in which case L is 0). In one aspect, when the average TEWL value is 0.1 to 9.9% of the second threshold (e.g., 0.1 to 5%, 1 to 6%, 2 to 7%, 3 to 8%, 4 to 9%, or 5 to 9.9% of the second threshold), L is K-10, except when K-10 is less than 0 (in which case L is 0).

[0146] How to identify and treat patients who require pressure ulcer intervention In one aspect, the present disclosure provides a method for identifying and treating a patient in need of pressure ulcer intervention, the method comprising the steps of obtaining multiple TEWL measurements at an anatomical site on the patient; determining an average TEWL value of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); and, if the average TEWL value exceeds the threshold, administering pressure ulcer intervention at the anatomical site; and, if the average TEWL value exceeds the threshold, obtaining multiple TEWL measurements every two hours.

[0147] In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0148] In one aspect, the pressure ulcer intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction sheet cover, and a low-friction padded mattress surface.

[0149] In one aspect, the disclosure provides and encompasses a method for identifying and treating a patient in need of application of a barrier cream to the patient's heel, the method comprising the steps of: making multiple TEWL measurements on the patient's heel; calculating an average TEWL value from a portion of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); if the average TEWL value exceeds the threshold, applying the barrier cream to the patient's heel; and if the average TEWL value exceeds the threshold, making multiple TEWL measurements every two hours. In one aspect, if the average TEWL value exceeds the threshold, multiple TEWL measurements are made at least hourly or at least half-hourly.

[0150] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of neuromuscular stimulation to the patient's heel, the method comprising the steps of: making multiple TEWL measurements at the patient's heel; calculating an average TEWL value from a portion of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); if the average TEWL value exceeds the threshold, applying neuromuscular stimulation to the patient's heel; and making multiple TEWL measurements hourly if the average TEWL value exceeds the threshold. In one aspect, if the average TEWL value exceeds the threshold, multiple TEWL measurements are made at least half-hourly.

[0151] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of application of a topical cream to the patient's heel, the method comprising the steps of making a plurality of TEWL measurements on the patient's heel; calculating an average TEWL value from a portion of the plurality of TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); if the average TEWL value exceeds the threshold, applying the topical cream to the patient's heel; and if the average TEWL value exceeds the threshold, making a plurality of TEWL measurements every half hour.

[0152] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of a heeled boot to the patient's heel, the method comprising the steps of making a plurality of TEWL measurements on the patient's heel; calculating an average TEWL value from a portion of the plurality of TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); if the average TEWL value exceeds the threshold, applying a heeled boot to the patient's heel; and if the average TEWL value exceeds the threshold, making a plurality of TEWL measurements every half hour.

[0153] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of a barrier cream to the patient's sacrum, the method comprising the steps of making multiple TEWL measurements at the patient's sacrum, calculating an average TEWL value from a portion of the multiple TEWL measurements, determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater), applying the barrier cream to the patient's sacrum if the average TEWL value exceeds the threshold, and making multiple TEWL measurements every six hours if the average TEWL value exceeds the threshold. In one aspect, if the average TEWL value exceeds the threshold, the multiple TEWL measurements are made at least once every four hours, at least once every three hours, at least once every two hours, at least once every hour, or at least once every half hour.

[0154] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of neuromuscular stimulation applied to the patient's sacrum, comprising the steps of making multiple TEWL measurements at the patient's sacrum, calculating an average TEWL value from a portion of the multiple TEWL measurements, determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater), applying neuromuscular stimulation to the patient's sacrum if the average TEWL value exceeds the threshold, and making multiple TEWL measurements every four hours if the average TEWL value exceeds the threshold. In one aspect, if the average TEWL value exceeds the threshold, multiple TEWL measurements are made at least once every three hours, at least once every two hours, at least once every hour, or at least once every half hour.

[0155] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a topical cream to the patient's sacrum, the method comprising the steps of making multiple TEWL measurements at the patient's sacrum, calculating an average TEWL value from a portion of the multiple TEWL measurements, determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater), applying the topical cream to the patient's sacrum if the average TEWL value exceeds the threshold, and making multiple TEWL measurements every two hours if the average TEWL value exceeds the threshold. In one aspect, if the average TEWL value exceeds the threshold, the multiple TEWL measurements are made at least hourly or at least half-hourly.

[0156] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of ultrasound therapy, comprising the steps of: making multiple TEWL measurements at an anatomical site of the patient; calculating an average TEWL value from a portion of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); applying ultrasound therapy to the anatomical site if the average TEWL value exceeds the threshold; and making multiple TEWL measurements every two hours if the average TEWL value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient.

[0157] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of shockwave therapy, comprising the steps of: making multiple TEWL measurements at an anatomical site of the patient; calculating an average TEWL value from a portion of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); applying shockwave therapy to the anatomical site if the average TEWL value exceeds the threshold; and making multiple TEWL measurements every two hours if the average TEWL value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one aspect, shockwave therapy is provided by electromagnetic pulses or pressurized air.

[0158] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a 30-degree wedge, comprising the steps of making multiple TEWL measurements at an anatomical site of the patient, calculating an average TEWL value from a portion of the multiple TEWL measurements, determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater), applying a 30-degree wedge to the anatomical site if the average TEWL value exceeds the threshold, and making multiple TEWL measurements every two hours if the average TEWL value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0159] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a composite dressing, the method comprising the steps of making multiple TEWL measurements at an anatomical site of the patient, calculating an average TEWL value from a portion of the multiple TEWL measurements, determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater), applying the composite dressing to the anatomical site if the average TEWL value exceeds the threshold, and making multiple TEWL measurements every two hours if the average TEWL value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0160] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of a hybrid mattress, the method comprising the steps of: making multiple TEWL measurements at an anatomical site of the patient; calculating an average TEWL value from a portion of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); if the average TEWL value exceeds the threshold, providing a hybrid mattress to support the patient; and if the average TEWL value exceeds the threshold, making multiple TEWL measurements every two hours. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0161] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of a dynamic mattress, the method comprising the steps of: making multiple TEWL measurements at an anatomical site of the patient; calculating an average TEWL value from a portion of the multiple TEWL measurements; determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); if the average TEWL value exceeds the threshold, providing a dynamic mattress to support the patient; and if the average TEWL value exceeds the threshold, making multiple TEWL measurements every two hours. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0162] In one aspect, the present disclosure provides and encompasses a method for identifying and ambulating a bedridden patient in need, the method comprising the steps of providing a movement sensor with an accelerometer and a gyro sensor, monitoring the frequency and extent of patient movement, providing an alert if the movement sensor does not detect movement of more than a quarter turn for a specified period of time, and ambulating the patient upon the alert.

[0163] In one aspect, the present disclosure further provides and encompasses the step of administering an anatomy-specific intervention to a patient's anatomical site identified as injured by the combination of visual assessment and TEWL measurements. In one aspect, the anatomy-specific intervention is administered to a common site of wound development selected from the group consisting of the toes, heels, sacrum, spine, elbows, scapulae, occipital region, and ischial tuberosity. In one aspect, the anatomy-specific intervention is simultaneously administered to a second common site of wound development selected from the group consisting of the toes, heels, sacrum, spine, elbows, scapulae, occipital region, and ischial tuberosity. In one aspect, the first site receiving the anatomy-specific intervention is known to be responsible for the development of wounds at the second site.

[0164] Identification of damaged tissue by comparing bilateral TEWL measurements In one aspect, the present disclosure provides and encompasses a method for identifying damaged tissue, the method comprising the steps of obtaining a first TEWL measurement from a first location in tissue beneath a patient's skin, obtaining a second TEWL measurement from a second location bilaterally symmetrical to the first location, determining an average TEWL value for each of the first and second TEWL measurements, determining an average TEWL value from each of the first and second TEWL measurements, determining a difference in the average TEWL values ​​between the first and second TEWL measurements, and determining that tissue damage is present at the first or second location if the difference in the average TEWL values ​​exceeds a threshold.

[0165] 4A shows the sacral region of the back of a patient 410. A line of symmetry 412 can be drawn down the center of the back to divide the back into left and right mirror images. Point 414 is considered to be the left and right mirror image of the back of patient 410 because it is approximately the same distance and height from line of symmetry 412.

[0166] 4B shows left foot 420L and right foot 420R of patient 410 as they would appear if they were lying face up on a bed (not shown) with an observer standing at the foot of the bed. On the undersides 422L and 422R of feet 420L and 420R, locations 424L and 424R are at approximately equivalent locations (e.g., the same distance from the rear or heel and the same distance from the medial side of each foot 420L or 420R) and are considered symmetrical locations.

[0167] 4C illustrates additional exemplary symmetrical locations 432L and 432R located on the sides of feet 420L and 420R, and symmetrical locations 434L and 434R located on the bottom surfaces 422L and 422R of feet 420L and 420R, respectively. In one aspect, locations 432R and 430R are considered symmetrical with respect to foot 420R when considered alone without reference to foot 420L.

[0168] Without being limited to a particular theory, comparing TEWL measurements taken at opposite locations can compensate for offsets in measurements from a particular patient relative to the patient population. For example, a patient may be dehydrated on a particular day when measurements are taken. Comparing TEWL values ​​of healthy tissue from the same patient in a dehydrated state may deviate from TEWL values ​​of the same tissue at the same location when the patient is well hydrated. If tissue at one location is healthy while tissue at the opposite location is damaged, comparing measurements taken at opposite locations will more reliably indicate tissue damage at one location, eliminating the "common mode" effect of variations in dehydration at both locations.

[0169] Measurements at multiple locations (e.g., a first measurement at a first location and a second measurement at a second location symmetrical to the first location) may be performed using a TEWL measurement device 600, such as that shown in Figure 6. In one embodiment, the device 600 includes a processor that may be configured, according to instructions stored on a non-transitory computer-readable medium, to determine characteristics of the measurements obtained at the multiple locations or parameters associated with or derived from the measurements (e.g., one or more of the difference, average, or differences from a common average of the TEWL values ​​resulting from each of the multiple measurements). In one embodiment, the device 600 includes a display configured to display one or more parameters associated with the measurements (e.g., the average TEWL value resulting from measurements obtained at two symmetrical locations).

[0170] In one embodiment, a difference in mean TEWL values ​​is determined, with a difference exceeding a predetermined threshold indicating tissue damage at one of the locations where the corresponding TEWL measurements were taken. In one embodiment, the average of the TEWL values ​​taken at each symmetrical location is determined and compared. In one embodiment, the median or mode of the mean TEWL values ​​taken at each symmetrical location is determined and compared. In one embodiment, damage is indicated at the location associated with a larger mean TEWL value. In one embodiment, damage is indicated at the location associated with a smaller mean TEWL value. In one embodiment, determining whether tissue damage is present includes one or more of comparing the individual mean TEWL values ​​to one or more predetermined ranges or thresholds and comparing the difference to one or more predetermined ranges or thresholds. In one embodiment, the predetermined range may be 0.1 to 8.0 (0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5, etc.). In one embodiment, the predetermined range may be 0.1 to 4.0 (0.5 to 4.0, 0.1 to 3.5, 1.0 to 3.5, 1.5 to 4.0, 1.5 to 3.5, 2.0 to 4.0, 2.5 to 3.5, 2.0 to 3.0, 2.0 to 2.5, or 2.5 to 3.0, etc.). In one embodiment, the predetermined range may be 4.1 to 8.0 (4.5 to 8.0, 4.1 to 7.5, 5.0 to 7.5, 5.5 to 7.0, 5.5 to 7.5, 6.0 to 8.0, 6.5 to 7.5, 6.0 to 7.0, 6.0 to 6.5, or 6.5 to 7.0, etc.). In one embodiment, the predetermined thresholds are approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the predetermined threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the predetermined range or threshold may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the predetermined value is not constrained by design, but rather, one of ordinary skill in the art may select the predetermined value. In one aspect, the ranges and thresholds of the present disclosure are modified according to the particular bilateral location, the part of the patient's body on which the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0171] One or more regions of the body may be defined. In one embodiment, measurements taken within a region may be considered comparable to one another. A region may be defined as an area on the skin of the body within which measurements may be taken at any point. In one embodiment, the region corresponds to an anatomical region (e.g., heel, ankle, hip). In one embodiment, the region may be defined as a set of two or more specific points relative to an anatomical feature at which measurements are only taken. In one embodiment, the region may include multiple discrete areas on the body. In one embodiment, the set of specific locations may include points in multiple discrete areas.

[0172] In one embodiment, the region is defined by a surface area. In one embodiment, the region is defined by a surface area, e.g., 5 to 200 cm. 2 , 5~100cm 2 , 5~50cm 2 , 10~50cm 2 , 10~25cm 2 , or 5 to 25 cm 2 may be.

[0173] In one embodiment, measurements may be taken in a specific pattern or portion thereof. In one embodiment, the pattern of measurements comprises a pattern centered around the area of ​​interest. In one embodiment, measurements are taken in one or more circular patterns of varying size, T-shaped patterns, a set of specific locations, or random traverses of the tissue or region. In one embodiment, the pattern may be positioned on the body by defining a first measurement location of the pattern relative to an anatomical feature and defining other measurement locations of the pattern as offsets from the first measurement location.

[0174] In one embodiment, the TEWL measurement device of the present disclosure may further include multiple contact sensors that are coplanar with each of the receivers and surround the receivers, thereby bringing the device into full contact with the skin surface. The multiple contact sensors may be multiple pressure sensors, multiple light sensors, multiple temperature sensors, multiple pH sensors, multiple sweat sensors, multiple ultrasound sensors, multiple bone growth sensors, or multiple combinations thereof. In one embodiment, the multiple contact sensors may include four, five, six, seven, eight, nine, ten, or more contact sensors.

[0175] 5A and 5B illustrate an example of a method for identifying symmetrical locations by comparing TEWL values ​​associated with measurements at known relative locations according to the present disclosure. In this example, a TEWL measurement device 630 is shown across the contact area 502R (e.g., 420R in FIG. 4C) on the right foot at non-overlapping locations marked "A" through "H" in FIG. 5A. The TEWL values ​​measured at each location are plotted on the graph in FIG. 5B. In this example, the TEWL values ​​at locations "A" and "H" are small or zero, reflecting that the TEWL measurement device 630 does not overlap the contact area 502R at these locations. The large TEWL values ​​associated with locations "B" and "G" are due to the TEWL measurement device 630 partially overlapping the contact area 502R at these locations. The TEWL values ​​at locations C, D, E, and F are large and, in this example, substantially the same, indicating that the TEWL measurement device 630 is completely within the contact area 502R at these locations. In one embodiment, a TEWL measurement device, such as TEWL measurement instrument 630, may determine that certain locations (e.g., locations "C" and "F") are symmetrical about centerline 504R of right foot 420R. In one embodiment, if a similar set of measurements is taken at locations A'-H' on left foot 420L, locations on each foot 420L and 420R (e.g., locations E and E') may be determined to be approximately symmetrical.

[0176] FIG. 6 is a schematic diagram of an integrated system 600 for measuring, evaluating, storing, and transferring TEWL measurement results according to the present disclosure. In this example, the system 600 includes a TEWL measurement device 630 capable of wirelessly communicating with a Wi-Fi access point 610. The TEWL measurement device 630 communicates with one or more of a TEWL measurement application running on a server 650, a laptop computer 620, a smartphone 640, or an application running on another digital device. In one embodiment, the laptop computer 620 and the smartphone 640 are carried by a user of the TEWL measurement device 630 (e.g., a nurse), and the application provides feedback and information to the user. In one embodiment, patient information received from the TEWL measurement device 630 is stored in a database 660. In one embodiment, the information received from the TEWL measurement device 630 is transferred via a network 655 to another server 680, which stores a portion of the information in the patient's electronic medical record (EMR) 670. In one embodiment, information from the TEWL measurement device 630 or information retrieved from the database 660 or EMR 670 is transferred to an external server 690 and then to a computer 695 (e.g., a computer in the office of a physician providing medical care to the patient).

[0177] Methods for detecting tissue damage before it becomes visible In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining multiple TEWL measurements at locations on the patient's skin at different times, determining an average TEWL value from each of the multiple TEWL measurements, calculating a slope between the most recent TEWL value and the immediately preceding TEWL value, comparing the slope to a threshold, and determining that tissue damage is present if the derivative exceeds the threshold. In one aspect, the method is performed at multiple locations.

[0178] In one embodiment, the slope between the most recent average TEWL value and the immediately preceding average TEWL value indicates tissue damage. In one embodiment, a positive slope between the most recent average TEWL value and the immediately preceding average TEWL value indicates worsening tissue damage. In one embodiment, a positive slope between the most recent average TEWL value and the immediately preceding average TEWL value indicates the formation of a pressure ulcer.

[0179] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of: obtaining multiple TEWL measurements at multiple locations on the patient's skin at different times; determining an average TEWL value from each of the multiple TEWL measurements; calculating a difference value between the maximum and minimum average TEWL values ​​for each time period; calculating a derivative with respect to time of the difference value; comparing the derivative to a threshold; and determining that tissue damage is present if the derivative exceeds the threshold. In one aspect, the method is performed at multiple locations.

[0180] In one embodiment, the difference value between the maximum and minimum average TEWL values ​​per time indicates tissue damage. In one embodiment, the derivative of the difference value with respect to time is calculated from two different times. In one embodiment, the derivative of the difference value with respect to time is calculated from the two most recent difference values. In one embodiment, the derivative of the difference value with respect to time is calculated from the difference values ​​measured at two consecutive time points. In one embodiment, the derivative of the difference value with respect to time is calculated from the difference values ​​measured at two non-consecutive time points. In one embodiment, a positive derivative indicates worsening tissue damage. In one embodiment, a positive derivative indicates the formation of a pressure ulcer.

[0181] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of: obtaining a plurality of TEWL measurements at a location on the patient's skin at each of a plurality of time intervals; determining an average TEWL value from each of the plurality of TEWL measurements; calculating a difference value between the maximum and minimum average TEWL values ​​for each time interval; fitting a curve to a predetermined number of recent difference values; calculating the curvature of the fitted curve; comparing the curvature to a threshold; and determining that tissue damage is present if the curvature exceeds the threshold. In one aspect, the method is performed at multiple locations.

[0182] In one aspect, the curvature of the fitting curve of the difference values ​​over time is indicative of tissue damage. In one aspect, an increase in the curvature of the fitting curve of the difference values ​​over time is indicative of worsening tissue damage. In one aspect, an increase in the curvature of the fitting curve of the difference values ​​over time is indicative of the formation of a pressure sore.

[0183] In some embodiments, multiple TEWL measurement results are obtained at different times. In one embodiment, the time difference is approximately once every second, approximately once every 15 seconds, approximately once every 30 seconds, approximately once every minute, approximately once every 10 minutes, approximately once every 15 minutes, approximately once every 30 minutes, approximately once every hour, approximately once every 2 hours, approximately once every 3 hours, approximately once every 4 hours, approximately once every 6 hours, approximately once every 12 hours, approximately once every 24 hours, approximately once every day, approximately once every 2 days, approximately once every 3 days, approximately once every 4 days, approximately once every 5 days, approximately once every 6 days, approximately once every 7 days, approximately once every 8 days, approximately once every 9 days, approximately once every 10 days.

[0184] In one embodiment, the threshold values ​​are approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.10, 4.11, 4.12, 4.13, 4.14, 4.15, 4.16, 4.17, 4.18, 4.19, 4.20, 4.21, 4.22, 4.23, 4.24, 4.25, 4.26, 4.27, 4.28, 4.29, 5.30, 5.31, 5.32, 5.33, 5.34, 5.35, 5.36, 5.37, 5.38, 5.39, 5.40, 5.41, 5.42, 5.43, 5.44, 5.45, 5.46, 5.47, 5.48, 5.49, 5.50, 5.51, 5.52, 5.53, 5.54, The color may be 4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art may select a predetermined value. In one embodiment, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body on which the measurement is being performed, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0185] In one embodiment, the number of TEWL values ​​above a predetermined threshold indicates epidermal damage that may lead to a pressure ulcer. The time interval between the first TEWL value above this threshold and the occurrence of visible symptoms of a pressure ulcer can be the first duration during which the TEWL value increases linearly. The first duration can be 5 days or more (6 days or more, 7 days or more, 8 days or more, 9 days or more, or 10 days or more).

[0186] In another embodiment, if a plot of TEWL values ​​over time shows an upward curvature or other deviation from a linear progression, visible symptoms may appear within a shorter time period (e.g., 2-3 days, 1-4 days, 1-3 days, 1-2 days, or 2-4 days). These TEWL values ​​are tracked and analyzed for trends in the TEWL values, i.e., the slope and curvature of the curve connecting these TEWL values. In one embodiment, the amount by which an incremental TEWL value exceeds a linear prediction based on the preceding TEWL values ​​is compared to a predetermined threshold. In one embodiment, the amount by which an incremental TEWL value exceeds the most recent preceding TEWL value is compared to a predetermined threshold. In one embodiment, the curvature of a best-fit curve fitted to a predetermined number of recent TEWL values ​​is compared to a predetermined threshold. In one embodiment, the number of consecutive TEWL values ​​that exceed a predetermined threshold is compared to a measurement count threshold. In each of these embodiments, the TEWL measurement scanner notifies the user when the comparison parameter exceeds each threshold.

[0187] In one embodiment, the trend analysis may disregard the number of single TEWL values ​​below a threshold value if both the preceding and subsequent TEWL values ​​are above the threshold value.

[0188] In one embodiment, the trend curve of the TEWL values ​​is a straight line connection between the points. In one embodiment, the trend curve is a best-fit curve fitted to the TEWL values. In one embodiment, the fitted curve is required to intersect with the most recent number of TEWL values.

[0189] Having generally described the invention above, the same will be more readily understood by reference to the following examples, which are provided for illustrative purposes and are not intended to limit the disclosure unless specified. [Example]

[0190] Example 1: Intervention Levels for Treating Pressure Ulcers of the Heel

[0191] Subjects identified as being at risk for heel pressure ulcers are treated according to the following scheme.

[0192] One or more TEWL measurements are taken of the patient at the heel. An average TEWL value is calculated. The patient is assigned an intervention level based on the average TEWL value compared to a threshold intensity, as shown in Table 1. An appropriate intervention corresponding to the assigned intervention level is implemented. Subsequent TEWL measurements are also performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either higher or lower) or kept the same, depending on the average TEWL value of the subsequent measurements.

[0193] Table 1: Exemplary intervention scheme for treating heel pressure ulcers JPEG2025134850000002.jpg132167

[0194] Example 2: Intervention Levels for Treating Sacral Pressure Ulcers

[0195] Subjects identified as being at risk for sacral pressure ulcers are treated according to the following scheme.

[0196] One or more TEWL measurements are taken of the patient at the sacrum. An average TEWL value is calculated. The patient is assigned an intervention level based on the average TEWL value compared to the threshold intensity, as shown in Table 2. An appropriate intervention corresponding to the assigned intervention level is performed at the sacrum. Subsequent TEWL measurements are also performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either higher or lower) or kept the same, depending on the average TEWL value of the subsequent measurements.

[0197] Table 2: Exemplary intervention scheme for treating sacral pressure ulcers JPEG2025134850000003.jpg111166

[0198] Example 3: Treatment decision pathway to stratify patients and provide appropriate treatment

[0199] Pressure ulcers are classified as stages 1 through 4, with stage 1 being the least severe. The National Pressure Ulcer Advisory Panel (NPUAP) defines a stage 1 ulcer as a localized, nonblanching erythema on intact skin. The erythema (redness of the superficial layer of skin) is "blanchable" if it whitens when pressed, and "non-blanchable" if it remains red when pressed, possibly due to the presence of red blood cells outside of blood vessels (extravasation). In some patients, blanching erythema or changes in sensation, temperature, or consistency may precede visible changes. While all patients are potentially at risk, pressure ulcers are more likely to develop in critically ill patients or those with neurological disorders, movement disorders, nutritional disorders, poor posture, or deformities.

[0200] Currently, visual skin assessment (VSA) is the method of identifying pressure ulcers: trained healthcare professionals visually and tactilely assess the appearance of the skin, looking for changes in redness or tissue firmness, tissue temperature, or moisture.

[0201] Figure 1A outlines the currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients, as presented in the clinical guideline "Pressure ulcers: prevention and management," published by the National Institute for Health and Care Excellence (NICE) on April 23, 2014. These guidelines recommend that a risk analysis be performed on all patients admitted to a care facility, indicating one or more risk factors, such as significantly restricted mobility, significant sensory loss, past or current pressure ulcers, nutritional deficiencies, inability to self-position, or significant cognitive impairment. Risk assessment is typically performed using a scored checklist, such as the Braden Scale, which assesses the severity of specific risk factors. See, for example, Bergstrom et al., Nurs Res, 36(4):205–210 (1987). This scale consists of six subscales reflecting sensation, skin moisture, activity, movement, friction and shear, and nutritional status.

[0202] The risk assessment identifies patients as being at (i) low risk of developing a pressure ulcer, (ii) at risk of developing a pressure ulcer, or (iii) at high risk of developing a pressure ulcer. Depending on the level of risk they are classified as, they undergo follow-up evaluation with various sequences of treatments and visual assessments.

[0203] If a patient is identified as being at low risk for developing a pressure ulcer, they are simply monitored for changes in their clinical status (e.g., events such as surgery, worsening of underlying conditions, changes in mobility). Patients who use wheelchairs or who sit for long periods of time may be provided with high-performance foam chair cushions or equivalent pressure-redistributing cushions. If there is no change in clinical status, low-risk patients will not be reassessed under this set of guidelines and will remain in the same treatment and evaluation pathway until discharge from the healthcare facility.

[0204] If a patient is identified as at risk for developing a pressure ulcer, they will be scheduled for repositioning, or "roundings," every six hours. As with low-risk patients, patients may be provided with high-performance foam chair cushions if they use a wheelchair or sit for long periods of time. No other monitoring or intervention is recommended under the NICE guidelines.

[0205] If a patient is identified as being at high risk for developing a pressure ulcer, they will receive a high-performance foam mattress as a preventative measure, or if they use a wheelchair or sit for long periods of time, they will be provided with a high-performance chair cushion. Patients will also be repositioned every four hours. Patients will undergo daily VSAs of all areas of their body. If an area shows non-blanching erythema, appropriate intervention will be implemented and the area will be rechecked with VSAs every two hours. Areas not showing non-blanching erythema will be rechecked daily with VSAs. Each high-risk patient will have an individualized medical care plan.

[0206] This flowchart (Figure 1A) shows that caregivers spend the majority of their time with high-risk patients. While this may be appropriate, it also means that at-risk patients may be left unmonitored and develop a Stage 1 ulcer before the condition is detected by caregivers. Furthermore, relying on VSA to detect a problem necessarily means that patients will develop a Stage 1 ulcer before intervention can be selected or implemented. By the time damage has progressed to Stage 1, intervention is likely to result in skin breakdown and a Stage 2 ulcer. Early detection of tissue damage is clearly necessary so that intervention can prevent subepidermal damage from progressing beyond Stage 1.

[0207] Figure 1B is an example of an enhanced treatment decision pathway for pressure ulcer prevention currently implemented in some healthcare facilities. The enhanced pathway adds a monitoring step to both the high-risk and low-risk pathways. Low-risk patients would undergo a weekly risk assessment (e.g., completing a Braden Scale assessment). At-risk patients would receive a high-performance foam mattress as a preventative measure and would be assessed daily with a VSA. A medical care plan would be developed to monitor and treat at-risk patients. There would be no change in the medical care of high-risk patients.

[0208] This expanded plan has the advantage of providing baseline monitoring of pressure ulcers for all patients. However, these additional steps require additional time due to increased staffing or increased strain on existing staff. While the care pathway in Figure 1B is superior to the recommended care pathway in Figure 1A, it requires more resources and still has the limitation that patients must have a stage 1 ulcer before the VSA can identify the injury.

[0209] Different hospitals and healthcare facilities use different numbers of risk categories. These range from two categories (low risk and high risk) to four or more categories, with additional categories such as "very high risk" in addition to the categories shown in the example in Figure 1B. Patients are assigned to various categories based on the results of their initial risk assessment.

[0210] FIG. 2 is an exemplary flowchart of a method in which a device for evaluating TEWL measurements in tissues beneath a patient's skin may be used in an independent process to prevent pressure ulcers according to the present disclosure. Every patient visit undergoes a complete TEWL measurement assessment of all body locations selected for monitoring. These selected locations may include areas recommended in the TEWL measurement device's Instructions for Use (IFU), such as the sacrum and heels. Additional locations may be identified by hospitals and incorporated into their in-house practices. Multiple TEWL measurements are taken at and around each selected body location at spatially distinct locations. From the set of measurements, an average TEWL value for each location is calculated for that location and its surroundings. The average TEWL value is then compared to one or more thresholds to classify the patient.

[0211] In this example, patients are assigned to one of two risk categories: low risk and high risk. Low-risk patients undergo weekly TEWL measurements at all body sites selected for monitoring. This is a low-cost approach, yet beneficial for even the healthiest patients, as weekly TEWL scans increase the likelihood of detecting tissue damage before it becomes visible on VSA.

[0212] At-risk patients, which would include those identified as high-risk in the current healthcare pathway of Figures 1A and 1B, would receive specialized healthcare based on the body location that exhibits a TEWL value above a threshold. For example, if the TEWL value at the sacrum is above a threshold, the patient would be repositioned every six hours and would also receive daily TEWL measurements at the sacrum, while other body locations, such as the heel, would receive weekly TEWL measurements.

[0213] 3 is a flowchart of a method in which a device for measuring pressure in tissue beneath a patient's skin may be used to further refine the extended treatment decision pathway of FIG. 1B, according to the present disclosure. An incoming patient undergoes both a risk assessment and TEWL measurement scans of all body locations identified by the hospital for monitoring, with the patient's assignment to a risk category based in part on the risk assessment and TEWL measurement scans. An initial TEWL value greater than a threshold indicates the possibility of injury at that body location.

[0214] Currently, the decision to perform an intervention (e.g., repositioning the patient at the first interval) is based on VSA and risk assessment, even though it is unknown whether early-stage damage exists beneath the skin. However, when TEWL measurement is used as an adjunct to the extended treatment decision pathway as shown in FIG. 3, the decision to perform an intervention at a particular body location is based on the TEWL value found at that location in the TEWL measurement scan. If the TEWL value is below a predetermined threshold, no intervention is required. If the TEWL value is above a predetermined threshold, an intervention is selected and performed based in part on the body location and the TEWL value at that body location. The predetermined threshold for selecting and performing an intervention may be higher or lower than the threshold for determining that damage may exist at that body location.

[0215] One of the advantages of utilizing TEWL measurement devices to monitor patients becomes clear from a comparison of the costs of providing the healthcare pathways shown in Figures 1A, 1B, 2, and 3. However, the costs quoted herein are for patients who do not have or develop a pressure ulcer, where the estimated cost of treatment jumps to $2000 for a stage 1 ulcer.

[0216] The baseline for this comparison is the expanded current system in Figure 1B, which represents current "best practice" for hospitals striving to reduce pressure ulcer incidence. Low-risk care pathway care delivery is expected to cost an average of $26 per patient with an average hospital stay of 5.6 days, while care for at-risk patients is expected to cost an average of $121 and care for high-risk patients is expected to cost $165. All current care pathways rely on VSA to detect pressure ulcers and otherwise implement interventions based on a "typical" patient's course rather than a specific patient's condition.

[0217] As shown in Figure 3, incorporating a TEWL measurement device into the current "best practice" workflow does not reduce the costs of either care pathway because it does not eliminate the work element. However, the benefit is early detection of tissue damage with minimal incremental cost. The incremental cost of adding a TEWL measurement scan to the low-risk care pathway is $2, increasing costs from approximately $26 to $28. The expected cost of care for at-risk patients without high TEWL values, i.e., those without subepidermal tissue damage, also increases by $2. However, if an at-risk patient is found to have high TEWL values, that patient would be elevated to the high-risk category, increasing the expected cost of care from $165 to $169. This represents a small incremental cost relative to the benefit of early detection of tissue damage in both low-risk and at-risk patients.

[0218] Figure 2 depicts an exemplary workflow that relies solely on TEWL measurement devices to monitor patients without the use of conventional VSA. The expected cost of preventive care for low-risk patients using TEWL measurement alone is $4, compared to $28 using the integrated low-risk care pathway of Figure 3. As shown in Figure 2, for at-risk patients using TEWL measurement alone, the expected cost is $97, compared to $123-$169 for at-risk and high-risk patients using the integrated care pathway of Figure 3.

[0219] Example 4: Risk Levels Based on TEWL Values

[0220] Subjects identified as being at risk for pressure ulcers are treated according to the following scheme.

[0221] One or more TEWL measurements are obtained for a patient at one or more target body locations. An average TEWL value is calculated for each scanned body location. Average TEWL values ​​are previously obtained for many patients at various body locations, both with and without pressure injuries, and used to construct a histogram of average TEWL values. As shown in Table 3, patients with average TEWL values ​​in the first tertile (less than 33.3% of maximum intensity) are assigned to risk level 0, while patients with average TEWL values ​​in the second tertile (33.3–66.6% of maximum intensity) and the third tertile (greater than 66.6% of maximum intensity) are assigned to risk levels 1 and 2, respectively. Appropriate interventions corresponding to the assigned risk level are implemented. Subsequent TEWL measurements are performed at a frequency determined by the assigned intervention level. A patient's assigned intervention level may be changed (either higher or lower) or kept the same depending on the average TEWL value of subsequent measurements.

[0222] Table 3: Exemplary intervention scheme for treating patients at risk for pressure ulcers JPEG2025134850000004.jpg70170

[0223] From the above, it will be appreciated that the present invention can be embodied in a variety of forms, including but not limited to the following.

[0224] Embodiment 1. A method for evaluating TEWL measurement results in tissue beneath intact skin of a patient, the method comprising the steps of: (a) obtaining a TEWL measurement scan on the patient's skin; and (b) generating a TEWL measurement map.

[0225] Embodiment 2. A method for reducing the incidence of tissue injury in patients admitted to a healthcare facility, comprising: (a) assessing the patient for risk of tissue injury upon admission to the healthcare facility, the step comprising: (i) obtaining TEWL measurements of the patient at one or more body locations at risk for wound development; and (ii) determining an average TEWL value of the TEWL measurements; (b) implementing a Level 0 intervention if the average TEWL value is below a first threshold; and (c) implementing a Level N intervention, where N is an integer greater than or equal to 1, if the average TEWL value exceeds the first threshold.

[0226] Embodiment 3. The method of embodiment 2, wherein the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over bony prominences of the patient.

[0227] Embodiment 4. The method of embodiment 2 or 3, wherein the one or more body locations at risk for wound development include one or more anatomical sites in prolonged contact with a medical device.

[0228] Embodiment 5. The method of embodiment 4, wherein the body area at risk for wound development is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0229] Embodiment 6. A method for stratifying a plurality of patients at a healthcare facility based on level of care, comprising: (a) obtaining TEWL measurements of one of the plurality of patients at one or more body locations selected for monitoring; (b) determining an average TEWL value of the patient's TEWL measurements; (c) determining a healthcare level, among N levels of care, that corresponds to the average TEWL value; (d) assigning a healthcare level to the patient; and (e) placing the patient of the plurality of patients into a group based on each of the levels of care assigned to the patient.

[0230] Embodiment 7. The method of embodiment 6, wherein the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over bony prominences of the patient.

[0231] Embodiment 8. The method of embodiment 6, wherein the one or more body locations at risk for wound development include one or more anatomical sites in prolonged contact with a medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0232] Embodiment 9. A method of identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method comprising: (a) obtaining a plurality of TEWL measurements of the patient at one or more body locations; (b) determining an average TEWL value of the plurality of TEWL measurements of the patient; (c) providing one or more anatomical-specific interventions based on the average TEWL value; (d) increasing the level of the anatomical-specific intervention based on an increase in the average TEWL value; and (e) decreasing the level of the anatomical-specific intervention based on a decrease in the average TEWL value.

[0233] Embodiment 10. A method for assigning a patient in a healthcare facility to one risk category selected from a plurality of risk categories, the method comprising: (a) obtaining initial TEWL measurements at one or more body locations selected for monitoring; (b) determining an average TEWL value of the TEWL measurements; and (c) assigning the patient to one risk category selected from the plurality of risk categories based in part on the average TEWL value of the TEWL measurements.

[0234] Embodiment 11. The method of embodiment 10, wherein the body site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0235] Embodiment 12. The method of embodiment 10, wherein the body site comprises one or more anatomical sites in prolonged contact with the medical device and is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0236] Embodiment 13. A method of managing a patient's medical care, comprising: (a) obtaining a first set of TEWL measurements at one or more body locations selected for monitoring upon admission to a medical care facility; (b) determining a first average TEWL value for each of the first set of TEWL measurements; (c) setting an intervention level N=1 if one of the average TEWL values ​​of the first set of TEWL measurements exceeds a first threshold; (d) implementing level N of intervention for each of the one or more body locations whose average TEWL value exceeds the first threshold; (e) obtaining subsequent sets of TEWL measurements at each of the one or more body locations at a frequency of level N; and (f) determining a new average TEWL value for each of the one or more body locations.

[0237] Embodiment 14. The method of embodiment 13, wherein the one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0238] Embodiment 15. The method of embodiment 13, wherein the one or more body locations selected for monitoring include one or more anatomical sites in prolonged contact with the medical device and are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

[0239] Embodiment 16. A method for identifying and treating patients at risk for tissue damage, comprising: (a) assessing the patient for risk of tissue damage upon admission to a healthcare facility, the step comprising: (i) obtaining a first plurality of TEWL measurements of the patient; and (ii) determining a first average TEWL value of the initial set of TEWL measurements; (b) implementing a first intervention at level 0 if the first average TEWL value is less than or equal to a first threshold; and (c) implementing a first intervention at level N (N is an integer greater than or equal to 1) if the first average TEWL value is greater than the first threshold.

[0240] Embodiment 17. The method of embodiment 16, further comprising: (a) obtaining a second plurality of TEWL measurements of the patient at a first predetermined frequency corresponding to the level of intervention implemented; (b) determining a second average TEWL value of the second plurality of TEWL measurements; (c) determining whether the second average TEWL value exceeds a second threshold; (d) continuing to implement the first intervention if the second average TEWL value does not exceed the second threshold; (e) continuing to obtain a plurality of TEWL measurements at the first predetermined frequency if the second average TEWL value does not exceed the second threshold; (f) implementing a second intervention at level M (M is an integer greater than N) if the second average TEWL value exceeds the second threshold; and (g) obtaining a plurality of TEWL measurements at a second predetermined frequency corresponding to level M if the second average TEWL value exceeds the second threshold.

[0241] Embodiment 18. The method of embodiment 16 or 17, further comprising: (a) determining whether the second average TEWL value is less than a third threshold; (b) continuing to implement the first intervention if the second average TEWL value is greater than or equal to the third threshold; (c) continuing to obtain multiple TEWL measurement results at a first predetermined frequency if the second average TEWL value is greater than or equal to the third threshold; (d) implementing a third intervention at level L (L is an integer less than N) if the second average TEWL value is less than the third threshold and the first intervention is not level 0; and (e) obtaining multiple TEWL measurement results at a predetermined frequency corresponding to level L if the second average TEWL value is less than the third threshold.

[0242] Embodiment 19. The method of any one of embodiments 16 to 18, wherein the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0243] Embodiment 20. The method of any one of embodiments 17 to 19, wherein the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0244] Embodiment 21. The method of any one of embodiments 18 to 20, wherein the Level L third intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0245] Embodiment 22. The method of any one of embodiments 16 to 21, wherein the first average TEWL value is determined from a subset of the first plurality of TEWL measurements.

[0246] Embodiment 23. The method of any one of embodiments 17 to 22, wherein the second average TEWL value is determined from a subset of the second plurality of TEWL measurements.

[0247] Embodiment 24. The method of any one of embodiments 17 to 23, wherein the second threshold is equal to the first threshold.

[0248] Embodiment 25. The method of any one of embodiments 18 to 24, wherein the third threshold is equal to the first threshold.

[0249] Embodiment 26. A method for identifying and treating a patient requiring intervention for a pressure ulcer, comprising: (a) obtaining multiple TEWL measurements at an anatomical site of the patient; (b) determining an average TEWL value of the multiple TEWL measurements; (c) determining whether the average TEWL value exceeds a threshold corresponding to level N (N is 2 or greater); (d) administering an intervention for the pressure ulcer to the anatomical site if the average TEWL value exceeds the threshold; and (e) obtaining multiple TEWL measurements every two hours if the average TEWL value exceeds the threshold.

[0250] Embodiment 27. The method of embodiment 26, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0251] Embodiment 28. The method of embodiment 26 or 27, wherein the intervention for the pressure ulcer is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and low-friction padded mattress surfaces.

[0252] Embodiment 29. A method for identifying damaged tissue, comprising the steps of: (a) obtaining a first TEWL measurement result from a first location in tissue beneath the patient's skin; (b) obtaining a second TEWL measurement result from a second location bilaterally symmetrical to the first location; (c) determining an average TEWL value for each of the first and second TEWL measurements; (d) determining a difference in the average TEWL values ​​between the first and second TEWL measurements; and (e) determining that tissue damage is present at the first or second location if the difference in the average TEWL values ​​exceeds a threshold.

[0253] Embodiment 30. The method of embodiment 29, wherein the first location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0254] Embodiment 31. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) obtaining multiple TEWL measurements at a location in tissue beneath the patient's skin at different times; (b) determining an average TEWL value from each of the multiple TEWL measurements; (c) calculating the slope between the most recent average TEWL value and the immediately preceding average TEWL value; (d) comparing the slope with a threshold; and (e) determining that tissue damage is present if the slope exceeds the threshold.

[0255] Embodiment 32. The method of embodiment 31, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0256] Embodiment 33. The method of embodiment 31 or 32, performed at multiple locations.

[0257] Embodiment 34. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) obtaining multiple TEWL measurements at a location on the patient's skin at different times; (b) determining an average TEWL value from each of the multiple TEWL measurements; (c) calculating a TEWL difference between the maximum average TEWL value and the minimum average TEWL value for each time period; (d) calculating a derivative of the TEWL difference with respect to time; (e) comparing the derivative with a threshold; and (f) determining that tissue damage exists if the derivative exceeds the threshold.

[0258] Embodiment 35. The method of embodiment 34, wherein the plurality of locations is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0259] Embodiment 36. The method of embodiment 34 or 35, wherein the derivative of the difference value with respect to time is calculated from the two most recent difference values.

[0260] Embodiment 37. The method of any one of embodiments 34 to 36, performed at multiple locations.

[0261] Embodiment 38. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) obtaining multiple TEWL measurements at a location on the patient's skin at multiple time intervals; (b) determining an average TEWL value from each of the multiple TEWL measurements; (c) calculating the TEWL difference between the maximum average TEWL value and the minimum average TEWL value for each time interval; (d) fitting a curve to a predetermined number of recent TEWL differences; (e) calculating the curvature of the fitted curve; (f) comparing the curvature with a threshold; and (g) determining that tissue damage is present if the curvature exceeds the threshold.

[0262] Embodiment 39. The method of embodiment 38, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0263] Embodiment 40. The method of embodiment 38 or 39, performed at multiple locations.

[0264] While the present invention has been described with reference to specific embodiments, those skilled in the art will recognize that various modifications may be made and equivalents may be substituted for the elements without departing from the scope of the invention. Furthermore, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the present invention not be limited to the particular embodiments disclosed, but rather to include all embodiments coming within the scope and spirit of the appended claims.

Claims

1. 1. A method for assessing TEWL measurements in tissue beneath intact skin of a patient, comprising: a) obtaining a TEWL measurement scan on the patient's skin; b) generating a TEWL measurement map; A method comprising:

2. 1. A method for reducing the incidence of tissue damage in a patient admitted to a healthcare facility, comprising: a) assessing a patient for risk of tissue injury upon admission to said healthcare facility; i) obtaining TEWL measurements of said patient at one or more body locations at risk for wound development; ii) determining a mean TEWL value of the TEWL measurements; and b) implementing a Level 0 intervention if the average TEWL value is below a first threshold; c) implementing a level N intervention (N is an integer greater than or equal to 1) if the average TEWL value exceeds the first threshold; A method comprising:

3. 3. The method of claim 2, wherein the one or more body locations at risk of wound development are selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

4. 4. The method of claim 2 or 3, wherein the one or more body locations at risk of wound development include one or more anatomical sites in prolonged contact with a medical device.

5. 5. The method of claim 4, wherein the body area at risk of developing a wound is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

6. 1. A method of stratifying a plurality of patients at a healthcare facility based on level of healthcare care, comprising: a) obtaining TEWL measurements of one of the plurality of patients at one or more body locations selected for monitoring; b) determining a mean TEWL value of the TEWL measurements for the patient; c) determining a level of medical care among N levels of medical care that corresponds to said average TEWL value; d) assigning said level of care to said patient; e) placing the patients of the plurality of patients into groups based on respective levels of care assigned to the patients; A method comprising:

7. 7. The method of claim 6, wherein the one or more body locations at risk of wound development are selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

8. 7. The method of claim 6, wherein the one or more body locations at risk of developing a wound include one or more anatomical sites that are in prolonged contact with a medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

9. 1. A method of identifying and providing an appropriate level of medical care to a patient in a medical care facility, comprising: a) obtaining a plurality of TEWL measurements of the patient at one or more body locations; b) determining a mean TEWL value of the plurality of TEWL measurements for the patient; and c) providing one or more anatomical-specific interventions based on the mean TEWL value. d) increasing the level of anatomical-specific intervention based on the increase in the mean TEWL value; e) decreasing the level of anatomical-specific intervention based on the decrease in the mean TEWL value; A method comprising:

10. 1. A method of assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, comprising: a) obtaining initial TEWL measurements at one or more body locations selected for monitoring; b) determining an average TEWL value of the TEWL measurements; c) assigning the patient to a risk category selected from the plurality of risk categories based in part on the mean TEWL value of the TEWL measurements; A method comprising:

11. 11. The method of claim 10, wherein the body site is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

12. 11. The method of claim 10, wherein the body site comprises one or more anatomical sites in prolonged contact with a medical device and is selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

13. 1. A method of managing medical care for a patient, comprising: a) obtaining a first set of TEWL measurements at one or more body locations selected for monitoring upon admission to a healthcare facility; b) determining a first average TEWL value for each of the first set of TEWL measurements; c) setting an intervention level N=1 if one of the average TEWL values ​​of the first set of TEWL measurements exceeds a first threshold; d) implementing a level N intervention for each of the one or more body locations having an average TEWL value above a first threshold; e) obtaining subsequent sets of TEWL measurements at each of said one or more body locations at a frequency of level N; f) determining a new average TEWL value for each of said one or more body locations; A method comprising:

14. 14. The method of claim 13, wherein the one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

15. 14. The method of claim 13, wherein the one or more body locations selected for monitoring include one or more anatomical sites in chronic contact with the medical device and are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

16. 1. A method for identifying and treating a patient at risk for tissue damage, comprising: a) assessing a patient for risk of tissue injury upon admission to a healthcare facility; i) obtaining a first plurality of TEWL measurements for the patient; ii) determining a first average TEWL value of the initial set of TEWL measurements; and b) implementing a first intervention at level 0 if the first average TEWL value is less than or equal to a first threshold; c) implementing a first intervention at level N (N is an integer greater than or equal to 1) if the first average TEWL value is greater than the first threshold; A method comprising:

17. a) obtaining a second plurality of TEWL measurements of the patient at a first predetermined frequency corresponding to the implemented level of intervention; b) determining a second average TEWL value of the second plurality of TEWL measurements; c) determining whether the second average TEWL value exceeds a second threshold; d) continuing to implement the first intervention if the second average TEWL value does not exceed the second threshold; e) continuing to obtain multiple TEWL measurements at the first predetermined frequency if the second average TEWL value does not exceed the second threshold; f) implementing a second intervention at level M (M is an integer greater than N) if the second average TEWL value exceeds the second threshold; g) if the second average TEWL value exceeds the second threshold, obtaining a plurality of TEWL measurements at a second predetermined frequency corresponding to a level M; 17. The method of claim 16, further comprising:

18. a) determining whether the second average TEWL value is less than a third threshold; b) continuing to administer the first intervention if the second average TEWL value is greater than or equal to the third threshold; c) continuing to obtain multiple TEWL measurements at the first predetermined frequency if the second average TEWL value is greater than or equal to the third threshold; d) implementing a third intervention at level L (L is an integer less than N) if the second average TEWL value is less than the third threshold and the first intervention is not level 0; e) obtaining multiple TEWL measurements at a predetermined frequency corresponding to level L if the second average TEWL value is less than the third threshold; 18. The method of claim 16 or 17, further comprising:

19. 19. The method of any one of claims 16-18, wherein the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

20. 20. The method of any one of claims 17-19, wherein the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

21. 21. The method of any one of claims 18 to 20, wherein the Level L tertiary intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

22. The method of any one of claims 16 to 21, wherein the first average TEWL value is determined by a subset of the first plurality of TEWL measurements.

23. The method of any one of claims 17 to 22, wherein the second average TEWL value is determined by a subset of the second plurality of TEWL measurements.

24. The method according to any one of claims 17 to 23, wherein the second threshold value is equal to the first threshold value.

25. The method according to any one of claims 18 to 24, wherein the third threshold value is equal to the first threshold value.

26. 1. A method for identifying and treating a patient in need of intervention for a pressure ulcer, comprising: a) obtaining a plurality of TEWL measurements at anatomical sites on the patient; b) determining an average TEWL value from the plurality of TEWL measurements; c) determining whether the average TEWL value exceeds a threshold corresponding to level N, where N is 2 or greater; d) administering the pressure ulcer intervention to the anatomical site if the mean TEWL value exceeds the threshold; e) if the average TEWL value exceeds the threshold, obtaining multiple TEWL measurements every two hours; A method comprising:

27. 27. The method of claim 26, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

28. 28. The method of claim 26 or 27, wherein the intervention for the pressure ulcer is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

29. 1. A method for identifying damaged tissue, comprising: a) obtaining a first TEWL measurement from a first location in tissue beneath the patient's skin; b) obtaining a second TEWL measurement from a second location symmetrical to the first location; c) determining an average TEWL value for each of the first TEWL measurement and the second TEWL measurement; d) determining the difference in the average TEWL value between the first TEWL measurement and the second TEWL measurement; e) determining that tissue damage is present at the first location or the second location if the difference in mean TEWL values ​​exceeds a threshold; A method comprising:

30. 30. The method of claim 29, wherein the first location is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

31. 1. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: a) obtaining a plurality of time-staggered TEWL measurements at a location in tissue beneath the patient's skin; b) determining an average TEWL value from each of the plurality of TEWL measurements; c) calculating the slope between the most recent average TEWL value and the immediately preceding average TEWL value; d) comparing the slope to a threshold; e) determining that tissue damage is present if the slope exceeds the threshold; A method comprising:

32. 32. The method of claim 31, wherein the location is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

33. 33. The method of claim 31 or 32, which is performed at multiple locations.

34. 1. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: a) obtaining a plurality of time-staggered TEWL measurements at a location on the patient's skin; b) determining an average TEWL value from each of the plurality of TEWL measurements; c) calculating a TEWL difference between the maximum and minimum average TEWL values ​​for each hour; d) calculating the derivative with respect to time of said TEWL difference; e) comparing said derivative with a threshold; f) determining that tissue damage is present if the derivative exceeds the threshold; A method comprising:

35. 35. The method of claim 34, wherein the plurality of locations are selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

36. 36. A method according to claim 34 or 35, wherein the derivative with respect to time of the difference value is calculated from the two most recent difference values.

37. The method of any one of claims 34 to 36, performed at multiple locations.

38. 1. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: a) obtaining a plurality of TEWL measurements at a location on the patient's skin at a plurality of respective time intervals; b) determining an average TEWL value from each of the plurality of TEWL measurements; c) calculating a TEWL difference between the maximum and minimum average TEWL values ​​for each time difference; d) fitting a curve to a predetermined number of recent TEWL differences; e) calculating the curvature of the fitted curve; f) comparing said curvature to a threshold; g) determining that tissue damage is present if the curvature exceeds the threshold; A method comprising:

39. 39. The method of claim 38, wherein the location is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient.

40. 40. The method of claim 38 or 39, performed at multiple locations.

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