Strategic treatment of pressure ulcer using sub-epidermal moisture values

Abstract

To provide methods of reducing an incidence rate of pressure ulcers in a care facility.SOLUTION: The present disclosure provides methods of identifying a patient in need of pressure ulcer treatment and treating the patient with clinical intervention selected based on sub-epidermal moisture values. The present disclosure also provides methods of stratifying groups of patients based on pressure ulcer risks.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED PATENT APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 587,337, filed November 16, 2017, and U.S. Provisional Patent Application No. 62 / 693,810, filed July 3, 2018. The entire contents of these applications are incorporated herein by reference.

[0002] The present disclosure provides methods for identifying and treating patients in need of pressure ulcer treatment with clinical interventions selected based on subepidermal moisture levels. The present disclosure also provides methods for stratifying patient groups based on pressure ulcer risk and methods for reducing the incidence of pressure ulcers in nursing homes. [Background technology]

[0003] Skin is the largest organ in the human body. It is easily exposed to various types of damage and trauma. When the skin and its surrounding tissues are unable to redistribute external pressure and mechanical forces, ulcers can form. Prolonged and continuous exposure to even moderate pressure, such as the pressure on the skin surface on the back side of a supine patient caused by the patient's weight, can lead to decubitus ulcers. In the presence of other damage, such as neuropathy and peripheral tissue weakness that may be induced by diabetes, even periodic exposure to moderate pressure and stress can lead to ulcers, such as 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 acute care settings, up to 25% of elderly, immobile patients develop pressure ulcers. Infections and other complications from pressure ulcers are responsible for the deaths of approximately 60,000 patients in the United States annually.

[0005] It is desirable for society as well as patients to detect tissue damage before the skin breaks down and intervene with appropriate therapy to avoid further deterioration of the underlying tissue. The average cost to treat pressure-induced damage is only $2,000 at the earliest visible signs (stage 1 ulcer), but rises to $129,000 when the ulcer is deep enough to expose muscle or bone (stage 4 ulcer). Currently, patients usually receive universal prevention of decubitus ulcers, meaning that the prevention is not targeted to any specific anatomical site. Patients receive targeted local treatment of decubitus ulcers only after they reach a point where they are identifiable by visual evaluation. The current standard for detecting decubitus ulcers is by visual inspection, which is subjective, unreliable, untimely, and low specificity. Thus, even if a patient has signs of skin inflammation, the development of an ulcer, the patient will not receive targeted local treatment for the developing ulcer. Instead, the inflammation continues and a full-blown ulcer develops. Summary of the Invention

[0006] In one aspect, the present disclosure provides and includes a method for identifying and providing an appropriate level of decubitus ulcer care to a patient based on a plurality of subepidermal moisture (SEM) measurements. In some aspects, a patient is provided with increasingly more effective interventions for a decubitus ulcer based on changes in SEM measurements. In some aspects, a patient is provided with less intense interventions for a decubitus ulcer based on changes in SEM measurements.

[0007] In one aspect, the disclosure provides and includes a method of evaluating a patient, the method including the steps of performing an initial SEM scan of a body location selected for monitoring and assigning the patient to a risk category selected from a group including a plurality of risk categories, the assignment being based in part on the initial SEM scan of the body location.

[0008] In one aspect, the disclosure provides and includes a method of managing the care of a patient, the method including the steps of: upon admission, performing an initial assessment of the patient and an initial SEM scan of all body locations selected for monitoring; calculating an initial delta value for each body location selected for monitoring; if any initial delta value is greater than or equal to a first threshold, determining that the patient is deviant and setting an intervention level of N=1; for each body location having a delta value greater than or equal to the first threshold, implementing a Level-N intervention; and performing an SEM scan of all body locations at a Level-N frequency and calculating new delta values.

[0009] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of treatment for a pressure ulcer, the method comprising: assessing the patient for the patient's risk of a pressure ulcer upon admission to a care facility, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a level-0 first intervention if the first delta value does not exceed the first threshold; and administering a level-N first intervention if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1. In a further aspect, the disclosure provides and includes: performing a second plurality of SEM measurements on the patient at a first predetermined frequency corresponding to a level of intervention to be administered; calculating a second delta value from a portion of the second plurality of SEM measurements; determining whether the second delta value exceeds a second threshold; continuing to administer the first intervention if the second delta value does not exceed the second threshold; continuing to perform the plurality of SEM measurements at the first predetermined frequency if the second delta value does not exceed the second threshold; administering a second intervention at level-M if the second delta value exceeds the second threshold, where M is an integer and M is greater than N; and performing the plurality of SEM measurements at the second predetermined frequency corresponding to level-M if the second delta value exceeds the second threshold. In yet a further aspect, the disclosure provides and includes determining whether the second delta value is less than a third threshold, administering a level-(N-1) intervention if the second delta value is less than the third threshold and if the first intervention is not level-0, and taking a plurality of SEM measurements at a predetermined frequency corresponding to level-(N-1) if the second delta value is less than the third threshold.

[0010] In one aspect, the disclosure provides and includes a method of slowing the progression of development of a pressure ulcer in a patient in need thereof, comprising the steps of identifying a current intervention received by the patient at level-K, taking a plurality of subepidermal moisture (SEM) measurements on the patient, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a first threshold, continuing to administer the current intervention if the delta value does not exceed the first threshold, continuing to take the plurality of SEM measurements at a predetermined frequency corresponding to level-K if the delta value does not exceed the first threshold, administering a new intervention at level-N if the delta value exceeds the first threshold, where N has a value greater than K, and administering the new intervention at level-N if the delta value exceeds the first threshold, where N has a value greater than K. In a further aspect, the disclosure provides and includes determining whether the delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and taking a plurality of SEM measurements at a predetermined frequency corresponding to level-L if the delta value is less than the second threshold.

[0011] In one aspect, the disclosure provides and includes a method of stratifying a group of patients in a care facility based on risk of pressure ulcer, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements for each patient, calculating a delta value from a portion of the plurality of SEM measurements for each patient, assigning a level of care to each patient based on whether each delta value exceeds any value in a set of thresholds corresponding to N levels of care, and reorganizing the patient groups based on each of the levels of care assigned to the patients.

[0012] In one aspect, the disclosure provides and includes a method of reducing the incidence of pressure ulcers in patients admitted to a nursing home, comprising the steps of: assessing the patient for risk of pressure ulcers upon admission to the nursing home, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a first intervention at level-0 if the first delta value does not exceed the first threshold; and administering a level-N intervention if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1.

[0013] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a protective cream to the patient's heel, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, applying a protective cream to the patient's heel if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every two hours if the delta value exceeds the threshold value.

[0014] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of neuromuscular stimulation to the patient's heel, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, administering neuromuscular stimulation to the patient's heel if the delta value exceeds the threshold value, and taking a plurality of SEM measurements hourly if the delta value exceeds the threshold value.

[0015] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a topical cream to the patient's heel, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, applying a topical cream to the patient's heel if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every 30 minutes if the delta value exceeds the threshold value.

[0016] In one aspect, the disclosure provides and includes a method for identifying and treating a patient in need of application of a protective cream to the patient's sacrum, the method comprising the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, applying a protective cream to the patient's sacrum if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every 6 hours if the delta value exceeds the threshold value.

[0017] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of neuromuscular stimulation to the patient's sacrum, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, administering neuromuscular stimulation to the patient's sacrum if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every four hours if the delta value exceeds the threshold value.

[0018] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a topical cream to the patient's sacrum, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, applying a topical cream to the patient's sacrum if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every two hours if the delta value exceeds the threshold value. [Brief description of the drawings]

[0019] The patent or application file contains at least one drawing executed in color. Copies of this patent or application publication containing a color drawing will be provided by the Office upon request and payment of the necessary fee.

[0020] Aspects of the disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the detailed drawings, it is emphasized that the specific items shown are by way of example and for the purpose of explanatory discussion of aspects of the disclosure. In this regard, the specification and drawings, considered either alone or in combination, make apparent to one skilled in the art how aspects of the disclosure may be practiced.

[0021] [Figure 1] FIG. 1 illustrates an example of an entire selection process for a decubitus ulcer treatment based on SEM value from nursing home admission to nursing home discharge in accordance with the present disclosure.

[0022] [Figure 2A] FIG. 2A is a sample of a visual assessment of healthy tissue in accordance with the present disclosure.

[0023] [Figure 2B] FIG. 2B is a plot of the average values ​​of SEM measurements taken at each location in and around a healthy sacrum in accordance with the present disclosure.

[0024] [Figure 3A] FIG. 3A is a sample of visual assessment of damaged tissue in accordance with the present disclosure.

[0025] [Figure 3B] FIG. 3B is a plot of the average values ​​of SEM measurements taken at each location at and around the injured sacrum in accordance with the present disclosure.

[0026] [Figure 4] FIG. 4 is an illustration of a process for selecting and monitoring an intervention level based on the amount by which a delta value derived from an SEM measurement exceeds a threshold in accordance with the present disclosure.

[0027] [Diagram 5] FIG. 5 is an example of a workflow guidance matrix for selecting a new intervention level using a current intervention level and a new delta value in accordance with the present disclosure.

[0028] [Figure 6A] 6A, 6B and 6C show an example of the progression of delta values ​​over time for one patient at a single site of developing decubitus ulcer in accordance with the present disclosure. [Figure 6B] Same as above. [Figure 6C] Same as above.

[0029] [Figure 6D] FIG. 6D is an example plot of the change in delta values ​​over time for one patient at a single location with a decubitus ulcer in accordance with the present disclosure.

[0030] [Figure 7A] 7A and 7B are examples of methods for mapping areas of tissue damage in accordance with the present disclosure. [Figure 7B] Same as above.

[0031] [Figure 8A]FIG. 8A is an example of a currently recommended treatment decision pathway for preventing decubitus ulcers in hospitalized patients that combines risk assessment and visual assessment.

[0032] [Figure 8B] FIG. 8B is an example of a current expanded treatment decision pathway for preventing decubitus ulcers as currently implemented in some medical facilities.

[0033] [Figure 9] FIG. 9 is an example flow chart of how a SEM scanner may be used in a stand-alone decubitus ulcer prevention treatment in accordance with the present disclosure.

[0034] [Figure 10] FIG. 10 is an example flow chart of how an SEM scanner may be used as an aid to further refine the expanded treatment decision pathway of FIG. 8B in accordance with the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] This specification is not intended to be a detailed inventory of all of the various ways in which this disclosure may be practiced or all of the features that may be added to the present disclosure. For example, features described in accordance with one embodiment may be incorporated in other embodiments, and features described in accordance with a particular embodiment may be omitted from that embodiment. That is, this disclosure contemplates that in some embodiments of this disclosure, it is possible to exclude or omit any feature or combination of features specified herein. Furthermore, multiple modifications and additions to the various embodiments suggested herein will become apparent to those skilled in the art in light of the present disclosure, which do not depart from the present disclosure. In other instances, well-known structures, interfaces, and processes have not been shown in detail in order not to unnecessarily obscure the present invention. It is intended that no part of this specification be construed as resulting in a disclaimer of any portion of the full scope of the present invention. Thus, the following description is intended to describe some specific embodiments of the present disclosure, and not to fully specify all permutations, combinations, and variations thereof.

[0036] 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 in the description of the description herein is for the purpose of describing particular aspects or embodiments only and is not intended to be limiting of the disclosure.

[0037] 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 occurs. References to technology used herein are intended to refer to technologies as commonly understood in the art, and include modifications of those technologies, or equivalent substitutions of technologies that would be apparent to one of ordinary skill in the art.

[0038] U.S. Patent Application Serial No. 14 / 827,375 ("the '375 Application") discloses an apparatus that uses radio frequency (RF) energy to measure subepidermal capacitance with a bipolar sensor, which corresponds to the water content of a target area of ​​a patient's skin. The '375 Application also discloses an array of bipolar sensors of various sizes.

[0039] U.S. Patent Application No. 15 / 134,110 discloses a subepidermal moisture (SEM) measurement device similar to that shown in FIG. 3, which emits and receives RF signals at a frequency of 32 kHz via a single coaxial sensor to generate a bioimpedance signal which is then converted to a SEM value.

[0040] Both U.S. Patent Application Nos. 14 / 827,375 and 15 / 134,110 are incorporated herein by reference in their entirety. However, the SEM values ​​herein may be measured by any similar or equivalent device or technique as would be apparent to one of ordinary skill in the art. For example, the device that measures the SEM values ​​herein may be a wired device, a wireless device, or a system that includes various components that communicate with each other.

[0041] Unless otherwise indicated in the context, it is specifically contemplated that the various features of the disclosure described herein can be used in any combination. Further, the present disclosure also contemplates that in some embodiments of the disclosure, it is possible to exclude or omit any feature or combination of features explicitly described herein.

[0042] The methods disclosed herein include and comprise one or more steps or actions for achieving the described method. The steps and / or actions of the methods may be interchanged with one another without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for 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.

[0043] As used in the description 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 indicates otherwise.

[0044] As used herein, "and / or" refers to and includes any and all possible combinations of one or more of the associated listed items, but also does not include combinations when interpreted in the alternative ("or").

[0045] As used herein, the terms "about" and "approximately" when referring to measurements such as length, frequency, or SEM values ​​are meant to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.5%, or ±0.1% of the particular amount.

[0046] As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted as including X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y", and phrases such as "from about X to Y" mean "from about X to about Y".

[0047] As used herein, the term "sub-epidermal moisture" or "SEM" refers to an increase in tissue fluid and localized edema caused by vascular leakage and other changes that alter the underlying structure of damaged tissue in the presence of continued pressure on the tissue, apoptosis, necrosis, and inflammatory processes.

[0048] As used herein, a "patient" can be a human or animal subject.

[0049] As used herein, "delta" refers to the calculated difference between two SEM values.

[0050] As used herein, the variables "K", "L", "M" and "N" are non-negative integers.

[0051] FIG. 1 illustrates an overall process 100 for selecting a decubitus ulcer treatment based on SEM values ​​generated by SEM measurements made using a SEM scanner according to the present disclosure, from admission to a care facility to discharge from the care facility. In one aspect, the care facility is selected from the group consisting of a hospital, an assisted living facility, a residential care facility, a nursing home, a long-term care facility, a continuing care community, and an independent living community. In one aspect, the care facility may be the patient's home or other residence, in which case the "enter" step 102 is an initial assessment of the patient in the patient's home by a nurse or other caregiver. In one aspect, the schedule of interventions and assessment intervals used in the home environment may differ from the corresponding interventions and intervals used in the hospital.

[0052] In one aspect, in process 100, a newly admitted patient undergoes an intake assessment at step 104, which includes 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 to evaluate one or more of nutrition, mobility, physical activity, strength, and communication ability; and SEM measurements taken at one or more locations on the patient's skin. In one aspect, the SEM measurements may include taking multiple SEM measurements at a single "location" on the patient's skin. In one aspect, a "location" is considered to be an area rather than a single point, such that SEM measurements may be made at spatially separated points within the location. For example, the location of the "heel" includes the medial, lateral, and posterior aspects of the heel circumference, as well as the posterior portion of the sole of the foot.

[0053] In one aspect, once the assessment steps are completed, a determination is made in step 106 as to whether the patient is "out of line", i.e., whether the combined results of the various components of the assessment indicate that the patient has or is at risk for developing tissue damage that may lead to a pressure ulcer. Each component of the assessment may have individual criteria for the level of risk, e.g., a scoring system with thresholds that indicate unacceptable risk. In one aspect, there is a protocol that combines the criteria to generate a composite parameter that can be used to select a level of intervention.

[0054] In one aspect, if the patient is determined to be at an acceptable risk level, the process proceeds to step 108 where a minimum level of intervention is implemented, referred to herein as "Level-Zero" or "Level-0". Proceeding from step 110 to step 112, the patient is re-evaluated using at least the SEM measurement protocol at step 114 at a frequency or conversely, time interval associated with Level-0. Process 100 then loops back to step 106 to evaluate the results of the SEM measurements made at step 114.

[0055] In one aspect, if the patient is determined to be deviant in step 106, then the process proceeds to step 122 where a higher level of intervention is implemented. In one aspect, there is a defined hierarchy of intervention levels with each level implementing a more effective intervention than the next lower level. In one aspect, each level also has a defined monitoring interval or frequency that indicates how often a set of SEM measurements should be taken, with higher levels generally having shorter intervals. In this example, the process was defined by the hospital or other governing body to go up one level to level-1 intervention at this point. In another aspect, step 122 may implement a level-2 or higher level of intervention. The process now enters a new loop beginning in step 130 where the patient is now monitored at a level-N frequency, where N ranges from 1 to n, and n is the highest level of intervention and monitoring defined.

[0056] In one aspect, at step 134, the patient's history is evaluated to determine whether their condition is improving. If the patient's condition is improving, for example as evidenced by a decrease in the delta value, then the process proceeds to step 142. In this example, step 142 continues to deliver the current level of intervention and the process loops from step 140 through steps 130-132-134-142-140 until the delta value falls below the threshold. In one aspect, the level of intervention can be decreased at step 142 based on the magnitude of the delta value as it decreases.

[0057] In one aspect, if the patient does not improve in step 134, the process proceeds to increase the level of intervention in step 138, provided that the skin has not broken down, i.e., not developed into an open ulcer, in step 136. If an open ulcer has developed, an SEM scan would now be performed around the perimeter of the open wound to map inflammation or other signs of the ulcer spreading, in step 144. The ulcer itself would be treated in step 148, and this secondary loop 144-146-148-150 would continue until the wound is closed, at which point the process would return to step 130.

[0058] In one aspect, at any point in process 100, patient discharge proceeds to step 118 where the patient's condition at the time of discharge or transfer is documented. In one aspect, step 118 includes a final set of SEM measurements at one of multiple locations on the patient's body. In one aspect, these locations include areas that did not receive intervention and areas not previously identified as at risk. In one aspect, this information is provided to the receiving caregiver. The patient is then discharged or transferred in step 120.

[0059] In one aspect, the present disclosure provides and includes a method of identifying and treating a patient in need of treatment for a pressure ulcer, the method comprising: assessing the patient for risk of a pressure ulcer upon admission to a care facility, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a level-0 first intervention if the first delta value does not exceed the first threshold; and administering a level-N first intervention if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1.

[0060] In one aspect, the first plurality of SEM measurements are taken at and around one or more anatomical locations selected from the group consisting of the sternum, sacrum, heels, scapulas, elbows, ears, and other fleshy tissues of the patient. In one aspect, the first plurality of SEM measurements are divided into subgroups for analysis based on the general location at which the measurements are taken. In one aspect, the first plurality of SEM measurements are taken at locations located in one or more concentric circles centered around the anatomical location. In one aspect, the first plurality of SEM measurements are taken at locations located on a line approximately equidistant from the anatomical location.

[0061] In one aspect, the first delta value is determined by the difference between the largest SEM value and the smallest SEM value from a first plurality of SEM measurements collected. In one aspect, the first delta value is determined by the difference between the largest SEM average of measurements taken at a first location and the smallest SEM average of measurements taken at a second location. In one aspect, the first delta value is determined for a portion of the first plurality of SEM measurements that comprise a subgroup defined by the locations taken. In one aspect, the average SEM value at a location is obtained from 2, 3, 4, 5, 6, 7, 8, 9, 10, or more SEM values ​​measured at that location. In one aspect, the first delta value is determined by the difference between SEM values ​​from measurements taken at two symmetric locations relative to a centerline.

[0062] In some aspects, the delta value may be calculated in a number of ways from multiple SEM measurements taken at a particular location or in the immediate vicinity of a particular location. In some aspects, the multiple SEM measurements are taken in a predefined pattern on the skin, and the delta value is calculated by subtracting an SEM value associated with a predefined location in the pattern from the largest SEM value taken at other locations in the pattern. In some aspects, the multiple SEM measurements are taken in a predefined pattern on the skin, and the delta value is calculated by identifying an SEM value associated with a predefined location in the pattern and subtracting the largest SEM value that occurred at other locations in the pattern. In some aspects, the average SEM value may be calculated from a portion of a set of SEM values ​​generated by multiple SEM measurements at a single location, and a delta value calculated as the largest difference between the average value of the same set and the single SEM value. In some aspects, the delta value may be calculated as the ratio of the largest SEM value to the smallest SEM value within the set of SEM values.

[0063] In one aspect, the first threshold may be about 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, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.20, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.30, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.40, 3.41, 3.42, 3.43, 3.44, 3.45, 3.46, 3.47, 3.48, 3.49, 3.50, 3.51, 3.52, 3.53, 3.54, 3.5 , 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 aspect, the first threshold value can range from 0.1 to 8.0, such as 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 some aspects, the first threshold value can be increased or decreased by a factor or multiple based on the values ​​provided herein. It will be understood that the threshold value is not limited by design, but rather, one of ordinary skill in the art will be able to select a predetermined value based on a given unit of SEM. In one aspect, the thresholds of the present disclosure vary depending on the particular part of the patient's body where the measurement is taken or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0064] In one aspect, N can range 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.

[0065] In one aspect, N is determined by the amount that the first delta value exceeds a first threshold. In one aspect, the amount by which the delta value exceeds the threshold set for (N+1) is greater than the amount by which the delta value exceeds the threshold set for N. In another aspect, the amount by which the delta value exceeds the threshold set for (N-1) is less than the amount by which the delta value exceeds the threshold set for N.

[0066] In one aspect, Level-1 (N=1) intervention is applied to patients having delta values ​​exceeding the threshold by 100% or less of the threshold, e.g., delta values ​​exceeding the threshold by 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.

[0067] In one aspect, Level-2 (N=2) intervention is applied to patients having delta values ​​exceeding the threshold by 150% or less than the threshold, e.g., delta values ​​exceeding the threshold by 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.

[0068] In one aspect, Level-3 (N=3) interventions are for delta values ​​exceeding the threshold by 200% or less of the threshold, e.g., 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 of the threshold. , or delta values ​​exceeding the threshold by 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.

[0069] In one aspect, Level-4 (N=4) interventions are for delta values ​​exceeding the threshold by 250% or less of the threshold, e.g., 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 of the threshold. , 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 above the threshold.

[0070] In one aspect, Level-5 (N=5) interventions are those where the delta value exceeds the threshold by 300% or less of the threshold, e.g., 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 of the threshold. , 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 above the threshold.

[0071] In one aspect, Level-6 (N=6) interventions are those where the delta value exceeds the threshold by 350% or less of the threshold, e.g., 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 of the threshold. , 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 above the threshold.

[0072] In one aspect, Level-7 (N=7) interventions are those where delta values ​​exceed the threshold by 400% or less of the threshold, e.g., 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, 32 5% 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, 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 above the threshold.

[0073] In one aspect, Level-8 (N=8) interventions are performed on delta values ​​exceeding the threshold by 450% or less of the threshold, e.g., 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 of the threshold. Lower, 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 Lower, 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, 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 above the threshold.

[0074] In one aspect, Level-9 (N=9) interventions are those where the delta value exceeds the threshold by 500% or less of the threshold, e.g., 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, 40% or less, 41% or less, 42% or less, 43% or less, 44% or less, 45% or less, 46% or less, 47% or less, 48% or less, 49% or less, 49% or less, 50% or less, 51% or less, 52% or less, 53% or less, 54% or less, 55% or less, 56% or less, 57% or less, 58% or less, 59% or less, 60% or less, 61% or less, 62% or less, 63% or less, 64% or less, 65% or less, 66% or less, 67% or less, 68% or less, 69% or less, 70% or less, 71% or less, 72% or less, 73% or less, 74% or less, 75% or less, 76% or less, 77% or less, 78% or less, 79% or less, 80% or less, 81% or less, 82% or less, 83% or less, 84 0% 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% Below, 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, 2 00% 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 above the threshold.

[0075] In one aspect, a Level-10 (N=10) intervention would be a delta value that exceeds the threshold by 550% or less of the threshold, e.g., 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 of the threshold. Below, 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, 3 65% 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 Lower, 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, 22 0% 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, 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 above the threshold.

[0076] In some respects, level-N interventions are more effective than level-0 interventions. In some respects, level-(N+1) interventions are more effective than level-N interventions. In some respects, level-(N-1) interventions are less effective than level-N interventions.

[0077] In some aspects, the evaluating step of the present disclosure further comprises performing a visual evaluation. In one aspect, the visual evaluation is performed according to NPUAP (National Pressure Ulcer Advisory Panel) guidelines.

[0078] In one aspect, the assessing step of the present disclosure further comprises performing a risk assessment, hi one aspect, 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.

[0079] In one aspect, the disclosure further provides and includes: performing a second plurality of SEM measurements on the patient at a first predetermined frequency corresponding to a level of intervention to be administered; calculating a second delta value from a portion of the second plurality of SEM measurements; determining whether the second delta value exceeds a second threshold; continuing to administer the first intervention if the second delta value does not exceed the second threshold; continuing to perform the plurality of SEM measurements at the first predetermined frequency if the second delta value does not exceed the second threshold; administering a second intervention at level-M if the second delta value exceeds the second threshold, where M is an integer and M is greater than N; and performing the plurality of SEM measurements at the second predetermined frequency corresponding to level-M if the second delta value exceeds the second threshold.

[0080] In one aspect, 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 30 minutes.

[0081] In one aspect, the second plurality of SEM measurements are taken in accordance with paragraph 0060. In one aspect, the second plurality of SEM measurements are taken at the same location as the first plurality of SEM measurements. In one aspect, the second plurality of SEM measurements are taken at a portion of the same location as the first plurality of SEM measurements. In one aspect, the second plurality of SEM measurements are taken proximate to the location of the first plurality of SEM measurements. In one aspect, the second plurality of SEM measurements are taken at a different location than the location of the first plurality of SEM measurements.

[0082] In one aspect, the second delta value is determined by the difference between the maximum SEM value and the minimum SEM value from the second plurality of SEM measurements collected. In one aspect, the second delta value is determined by the difference between the maximum SEM average of the measurements taken at the first location and the minimum SEM average of the measurements taken at the second location. In one aspect, the second delta value is determined for a portion of the second plurality of SEM measurements that comprises a subgroup defined by the locations taken.

[0083] In one aspect, the second threshold may be about 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, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.20, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.30, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.40, 3.41, 3.42, 3.43, 3.44, 3.45, 3.46, 3.47, 3.48, 3.49, 3.50, 3.51, 3.52, 3.53, 3.54, 3.5 , 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 aspect, the second threshold may range from 0.1 to 8.0, such as 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 aspect, the second threshold may be increased or decreased by a factor or multiple based on the values ​​provided herein. In one aspect, the second threshold may be the same as the first threshold. In one aspect, the second threshold may be greater than the first threshold. In one aspect, the second threshold may be less than the first threshold.

[0084] In one aspect, M ranges from 2 to 50, such as from 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.

[0085] In one aspect, M is determined by the amount by which the second delta value exceeds the second threshold. In one aspect, the amount by which the delta value exceeds the threshold set at (M+1) is greater than the amount by which the delta value exceeds the threshold set at M. In one aspect, the amount by which the delta value exceeds the threshold set at (M-1) is less than the amount by which the delta value exceeds the threshold set at M.

[0086] In one aspect, level M interventions are selected according to paragraphs 0066 through 0075, with M replacing N.

[0087] In one aspect, the disclosure further provides and includes determining whether the second delta value is less than a third threshold, administering a level-(N-1) intervention if the second delta value is less than the third threshold and if the first intervention is not level-0, and taking a plurality of SEM measurements at a predetermined frequency corresponding to level-(N-1) if the second delta value is less than the third threshold.

[0088] In one aspect, the third threshold is about 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, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.20, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.30, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.40, 3.41, 3.42, 3.43, 3.44, 3.45, 3.46, 3.47, 3.48, 3.49, 3.50, 3.51, 3.52, 3.53, 3.54, 3.55 , 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 aspect, the third threshold may range from 0.1 to 8.0, such as 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 aspect, the third threshold may be increased or decreased by a factor or multiple based on the values ​​provided herein. In one aspect, the third threshold may be the same as the second threshold. In one aspect, the third threshold may be greater than the second threshold. In one aspect, the third threshold may be less than the second threshold. In one aspect, the third threshold may be the same as the first threshold. In one aspect, the third threshold can be greater than the first threshold, hi one aspect, the third threshold can be less than the first threshold.

[0089] In one aspect, the second delta value can be 0.1 to 99.5% of the third threshold, e.g., 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%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 50%, 10 to 100%, 15 to 150%, 15 to 20%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 20%, 15 to 35%, 15 to 30%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 3 ... 35%, 25 to 50%, 25 to 75%, 45 to 55%, 50 to 60%, 55 to 65%, 60 to 70%, 65 to 75%, 40 to 55%, 50 to 75%, 50 to 99.5%, 70 to 80%, 75% to 85%, 80 to 90%, 85 to 95%, 90 to 99.5%, 65 to 85%, or 75 to 99.5% etc.

[0090] In one aspect, the disclosure provides and includes a method of slowing the progression of development of a pressure ulcer in a patient in need thereof, comprising: identifying a current intervention received by the patient at level-K; taking a plurality of subepidermal moisture (SEM) measurements on the patient; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a first threshold; continuing to administer the current intervention if the delta value does not exceed the first threshold; continuing to take the plurality of SEM measurements at a predetermined frequency corresponding to level-K if the delta value does not exceed the first threshold; administering a new intervention at level-N if the delta value exceeds the first threshold, N having a value greater than K; and taking the plurality of SEM measurements at a predetermined frequency corresponding to level-N if the delta value exceeds the first threshold. In one aspect, the patient in need thereof is a patient experiencing a change in care, a change in mobility, a change in nutrition, a change in sensory perception, or a combination thereof. In one aspect, the patient in need thereof is a patient developing an open ulcer. In one aspect, the patient in need thereof is a patient with an open ulcer healing. In one aspect, the patient in need thereof is a patient undergoing a surgical procedure. In one aspect, the patient in need thereof is a patient receiving spinal or sacral anesthesia during a surgical procedure. In one aspect, the patient in need thereof is a patient undergoing a surgical procedure lasting for 4 hours or more, such as 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 aspect, the surgical procedure lasts for 1 hour or more, such as 2 hours or more, or 3 hours or more.

[0091] In one aspect, the plurality of SEM measurements are taken in accordance with paragraph 0060. In an aspect, the delta value is determined in accordance with paragraph 0061. In one aspect, the first threshold value is determined in accordance with paragraph 0063.

[0092] In one aspect, K ranges from 2 to 50, e.g., from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2 to 10, from 2 to 15, from 2 to 20, from 2 to 25, from 2 to 30, from 2 to 35, from 2 to 40, or from 2 to 45, etc.

[0093] In one aspect, K is determined by the amount by which the delta value exceeds a threshold. In one aspect, the amount by which the delta value exceeds a threshold set at (K+1) is greater than the amount by which the delta value exceeds a threshold set at K. In one aspect, the amount by which the delta value exceeds a threshold set at (K-1) is less than the amount by which the delta value exceeds a threshold set at K.

[0094] In one aspect, level K interventions are selected according to paragraphs 0066 through 0075, with K replacing N.

[0095] In one aspect, the disclosure further provides and includes determining whether the delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and taking a plurality of SEM measurements at a predetermined frequency corresponding to level-L if the delta value is less than the second threshold.

[0096] In one aspect, the second threshold is determined in accordance with paragraph 0083.

[0097] In one aspect, 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 aspect, L is K-1 unless K-1 is less than 0, which would cause L to be 0 if the delta value is between 90 and 99.5% of the second threshold, such as between 90 and 95%, 91 and 96%, 92 and 97%, 93 and 98%, 94 and 99%, or 95 and 99.5% of the second threshold. In one aspect, L is K-2 if the delta value is between 80 and 89.9% of the second threshold, e.g., between 80 and 85%, 81 and 86%, 82 and 87%, 83 and 88%, 84 and 89%, or 85 and 89.9% of the second threshold, etc., unless K-2 is less than 0, at which point L will be 0. In one aspect, L is K-3 if the delta value is between 70 and 79.9% of the second threshold, e.g., between 70 and 75%, 71 and 76%, 72 and 77%, 73 and 78%, 74 and 79%, or 75 and 79.9%, etc., of the second threshold, unless K-3 is less than 0, at which point L will be 0. In one aspect, L is K-4 if the delta value is between 60 and 69.9% of the second threshold, e.g., between 60 and 65%, 61 and 66%, 62 and 67%, 63 and 68%, 64 and 69%, or 65 and 69.9%, etc., of the second threshold, unless K-4 is less than 0, at which point L will be 0. In one aspect, L is K-5 if the delta value is between 50 and 59.9% of the second threshold, e.g., between 50 and 55%, 51 and 56%, 52 and 57%, 53 and 58%, 54 and 59%, or 55 and 59.9%, etc., of the second threshold, unless K-5 is less than 0, at which point L will be 0. In one aspect, L is K-6 if the delta value is between 40 and 49.9% of the second threshold, e.g., between 40 and 45%, 41 and 46%, 42 and 47%, 43 and 48%, 44 and 49%, or 45 and 49.9%, etc., of the second threshold, unless K-6 is less than 0, at which point L will be 0. In one aspect, L is K-7 if the delta value is between 30 and 39.9% of the second threshold, e.g., between 30 and 35%, 31 and 36%, 32 and 37%, 33 and 38%, 34 and 39%, or 35 and 39.9%, etc., of the second threshold, unless K-7 is less than 0, at which point L will be 0. In one aspect, L is K-8 if the delta value is between 20 and 29.9% of the second threshold, e.g., between 20 and 25%, between 21 and 26%, between 22 and 27%, between 23 and 28%, between 24 and 29%, or between 25 and 29.9% of the second threshold, etc., in which case L will be 0 unless K-8 is less than 0.In one aspect, L is K-9 if the delta value is between 10 and 19.9% ​​of the second threshold, such as between 10 and 15%, 11 and 16%, 12 and 17%, 13 and 18%, 14 and 19%, or 15 and 19.9% ​​of the second threshold, unless K-9 is less than 0, at which point L will be 0. In another aspect, L is K-10 if the delta value is between 0.1 and 9.9% of the second threshold, such as between 0.1 and 5%, 1 and 6%, 2 and 7%, 3 and 8%, 4 and 9%, or 5 and 9.9%, of the second threshold, unless K-10 is less than 0, at which point L will be 0.

[0098] In one aspect, the disclosure provides and includes a method of stratifying a group of patients in a care facility based on risk of pressure ulcer, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements for each patient, calculating a delta value from a portion of the plurality of SEM measurements for each patient, assigning a level of care to each patient based on whether each delta value exceeds any value in a set of thresholds corresponding to N levels of care, and reorganizing the patient groups based on each of the levels of care assigned to the patients.

[0099] In one aspect, the disclosure provides and includes a method of reducing the incidence of pressure ulcers in patients admitted to a nursing home, comprising: assessing the patient for risk of pressure ulcers upon admission to the nursing home, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a level-0 first intervention if the first delta value does not exceed the first threshold; and administering a level-N first intervention if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1. In one aspect, the incidence of ulcers in nursing home 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.

[0100] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a protective cream to the patient's heel, the method comprising the steps of taking a plurality of subepidermal moisture (SEM) measurements on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 1, applying the protective cream to the patient's heel if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every two hours if the delta value exceeds the threshold value. In one aspect, the plurality of SEM measurements are taken at least once every hour or at least once every 30 minutes if the delta value exceeds the threshold value.

[0101] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of neuromuscular stimulation at the patient's heel, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to a level N, where N is greater than or equal to 1, administering neuromuscular stimulation to the patient's heel if the delta value exceeds the threshold, and taking a plurality of SEM measurements every hour if the delta value exceeds the threshold. In one aspect, the plurality of SEM measurements are taken at least once every 30 minutes if the delta value exceeds the threshold.

[0102] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a topical cream to the patient's heel, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2, applying a topical cream to the patient's heel if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every 30 minutes if the delta value exceeds the threshold value.

[0103] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a protective cream to the patient's sacrum, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to a level N, where N is greater than or equal to 1, applying the protective cream to the patient's sacrum if the delta value exceeds the threshold, and taking a plurality of SEM measurements every 6 hours if the delta value exceeds the threshold. In one aspect, the plurality of SEM measurements are taken at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, or at least once every 30 minutes if the delta value exceeds the threshold.

[0104] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of neuromuscular stimulation at the patient's sacrum, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to a level N, where N is greater than or equal to 1, administering neuromuscular stimulation to the patient's sacrum if the delta value exceeds the threshold, and taking a plurality of SEM measurements every 4 hours if the delta value exceeds the threshold. In one aspect, the plurality of SEM measurements are taken at least once every 3 hours, at least once every 2 hours, at least once every hour, or at least once every 30 minutes if the delta value exceeds the threshold.

[0105] In one aspect, the disclosure provides and includes a method of identifying and treating a patient in need of application of a topical cream to the patient's sacrum, the method including the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 1, applying the topical cream to the patient's sacrum if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every two hours if the delta value exceeds the threshold value. In one aspect, the plurality of SEM measurements are taken at least once an hour or at least once every 30 minutes if the delta value exceeds the threshold value.

[0106] In one aspect, the disclosed method is carried out using the apparatus disclosed in U.S. Patent Application Nos. 14 / 827,375 and 15 / 134,110. In one aspect, the moisture content is equivalent to the SEM value on a pre-determined scale. In one aspect, the pre-determined scale can range from 0 to 20, such as 0 to 1, 0 to 2, 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 11, 0 to 12, 0 to 13, 0 to 14, 0 to 15, 0 to 16, 0 to 17, 0 to 18, 0 to 19, etc. In one aspect, the pre-determined scale can be increased or decreased by a factor or multiple based on the values ​​provided herein.

[0107] In some aspects, the present disclosure further provides and includes providing targeted treatment to the patient's anatomical locations identified as damaged by a combination of visual assessment and SEM scan measurements. In one aspect, targeted treatment is provided to a common site for pressure ulcers selected from the group consisting of the toes, heels, sacrum, spine, elbows, shoulder blades, occipital region, and ischial tuberosity. In one aspect, targeted treatment is simultaneously provided to a second common site for pressure ulcers selected from the group consisting of the toes, heels, sacrum, spine, elbows, shoulder blades, occipital region, and ischial tuberosity. In one aspect, the first site receiving targeted treatment is known to cause the development of pressure ulcers at the second site.

[0108] The present disclosure is illustrated by the following examples. The examples set forth herein illustrate certain aspects of the present disclosure, but should not be construed as limiting the scope of the disclosure in any manner. EXAMPLES

[0109] Example 1: Intervention Levels for Treating Decubitus Ulcers on the Heel

[0110] Subjects identified as being at risk for pressure ulcers on the heel were treated according to the following scheme:

[0111] [Table 1]

[0112] Example 2: Intervention levels for treating decubitus ulcers in the sacrum

[0113] Subjects identified as being at risk for decubitus ulcers of the sacrum were treated according to the following scheme:

[0114] [Table 2]

[0115] Example 3: Identification of Patients Requiring Sacral Level-0 Intervention

[0116] The patient underwent multiple SEM measurements at and around the bony prominence of the sacrum using a device capable of taking SEM measurements. Prior to performing the measurements, surface moisture and material on the patient's skin surface was removed. The electrodes of the device were applied to the patient's skin with sufficient pressure to ensure complete contact for approximately one second to obtain each SEM measurement.

[0117] SEM measurements were taken on a line across the patient's sacrum. Multiple measurements were taken at a given measurement location. Figure 2A is a sample visual assessment of healthy tissue. Figure 2B is the corresponding plot of the mean value of the SEM measurements taken at each location. A threshold of 0.5 was selected. The delta value was calculated as the difference between the maximum and minimum mean SEM values, which was determined to be less than 0.5. As the SEM delta value fell below the threshold, the patient was identified as requiring level-0 intervention. Thus, the patient was placed on a standard mattress and repositioned every 24 hours.

[0118] Further SEM measurements were taken every 24 hours until discharge. There was no change in intervention levels.

[0119] Example 4: Identification of Patients Requiring Level-n Intervention in the Sacrum

[0120] Patients underwent multiple SEM measurements taken in a line transverse to the sacrum, following a procedure similar to that described in Example 3.

[0121] FIG. 3A is a sample visual assessment of the damaged tissue. FIG. 3B is the corresponding plot of the mean SEM measurements taken at each location. A threshold of 0.5 was selected. Delta values ​​were calculated as the difference between the maximum and minimum mean SEM values, which were determined to be greater than 0.5. Because the SEM delta values ​​exceeded the threshold by more than 200%, the patient was identified as requiring Level-8 intervention. Thus, the patient was placed on a silicone pad and monitored hourly until an SEM delta value less than 170% of the threshold was observed, at which point the patient was switched to Level-7 intervention.

[0122] Example 5: Example of a process for selecting levels of intervention and monitoring

[0123] 4 is a diagram of a process 400 for selecting a level of intervention and monitoring based on the amount that a delta value from SEM measurements exceeds a threshold, where in step 402 a caregiver uses an SEM scanner to take multiple SEM measurements at a location on the patient's skin, each measurement producing one SEM value. In step 404, a portion of these SEM values ​​are used to calculate a delta value "Δ". The delta value is calculated by subtracting the minimum SEM value from the maximum SEM value produced from the multiple SEM measurements.

[0124] The calculated delta value was compared to a threshold "T" in step 406. If the delta value was less than or equal to the threshold, step 408 was performed in which the caregiver waits until the monitoring interval associated with the current level of care occurs and then repeats the SEM measurement in step 402. If the delta value was greater than the threshold, the amount by which the delta value exceeded the threshold was compared to a cascaded series of different values.

[0125] In some instances, the delta value was positive and a comparison was performed by subtracting a threshold value from the delta value, which resulted in a positive difference, and then a determination was made as to whether the difference exceeded a first difference D1 in step 410. If the difference was less than D1, processing proceeded to step 412 and then to step 414, where an intervention and measurement interval, each associated with level -N+1, was implemented. In this example, N was a value equal to or greater than zero.

[0126] In some cases, the delta value is negative, for example if the SEM measurement at the center of the data in FIG. 3B is subtracted from the average of the SEM values ​​from the leftmost to the rightmost locations in FIG. 3B. In that case, the differences D1, D2 through Dn were selected to have negative values ​​that would have different absolute values ​​than the corresponding difference values ​​D1, D2 through Dn used for the positive delta values. Alternatively, the comparisons in steps 410, 420, and 430 were changed to "≦" instead of "≧" as shown in FIG. 4.

[0127] Example 6: Workflow Guidance Matrix

[0128] FIG. 5 is an example of a workflow guidance matrix 500 that uses a current intervention level 502 and a new delta value 504 to select a new intervention level 506. Here, a caregiver monitored a patient's condition by periodically taking multiple SEM measurements at one or more locations on the patient's skin. At the time of these measurements, the patient received care associated with a certain level of intervention and monitoring. In this example, level-0 (zero) is associated with patients who were not considered to be at significant risk for developing a pressure ulcer. Higher levels of intervention and monitoring were identified with tiers of intervention ranked according to, for example, cost, difficulty of implementation, or other parameters identified by the care facility. When a caregiver was taking a new set of SEM measurements, they consulted this matrix by identifying the row of the current intervention level 502, the delta value determined from the most recent set of SEM measurements 504, and identifying the intervention level in the cell 506 where the row 502 and column 504 intersect. The caregiver could consider not only the identified intervention level, but also the current intervention level and the delta value when selecting a level of intervention for the next time interval.

[0129] In some cases, the new intervention level values ​​in cells 506 were similar between rows. In some cases, the new intervention level values ​​in adjacent cells 506 differed by only one level or by more than one level. In some cases, the new intervention level values ​​in adjacent cells 506 were identical in adjacent cells.

[0130] Example 7: Progression of tissue conditions leading to decubitus ulcers

[0131] 6A, 6B, and 6C illustrate illustrative, non-limiting examples of the progression of tissue conditions over time that lead to decubitus ulcers. FIG. 6A illustrates a cross-section of healthy tissue 600, including the stratum corneum 602 and healthy cells 604 in the epidermis / dermis. The center electrode 606 and toroidal electrode 608 of the SEM scanner are shown in cross-section in contact with the stratum corneum 602. An illustrative representation of the sensitive region of the SEM scanner is shown as an elliptical region 610. This region 610 has a certain depth of sensitivity. In some instances, the depth of sensitivity is in the range of 0.14 to 0.16 inches. In some instances, the depth of sensitivity is less than 0.16 inches.

[0132] 6B shows an illustrative cross-section of slightly damaged tissue 620. Cellular damage, for example resulting from low levels of pressure applied over a long period of time, has affected the tissue. Without being limited to theory, some of the cells 622 burst and release their liquid contents into the intercellular spaces 624. Alternatively, and without being limited to theory, an inflammatory response causes the liquid to move into the intercellular spaces 624. This damage is not visible on the skin surface.

[0133] 6C is an illustrative cross-section 640 of a more advanced level of damage. Without being limited by theory, the tissue now has mostly ruptured cells 622, which may result in small mechanical structures that transmit continued pressure. As the tissue thickness decreases, bone 642 now comes closer to the skin surface. The ruptured cells 622 and intercellular spaces 624 are compressed, forcing fluid 644 out of the local tissue, as shown by arrows 646.

[0134] FIG. 6D is an illustrative plot 660 of delta values ​​for one patient at a single location with a decubitus ulcer. The SEM values ​​were measured by an SEM scanner. The delta values ​​were generated from a set of SEM measurements taken at incremental times. Point 672 is the measurement at time=zero, when all of the SEM values ​​have the baseline value associated with healthy tissue and the delta value is zero. At time t1, another set of SEM measurements was taken and the associated delta value is shown at point 674. This delta value was below the threshold 662 and therefore not indicative of significant subsurface damage.

[0135] At time t2, the damage had progressed and the delta value 676 was greater than the threshold value 662, indicating significant damage. This damage was not yet visible on the skin. Nevertheless, the delta value being greater than the threshold value 662 indicated cellular damage at a depth shallower than the depth of sensitivity of the SEM scanner.

[0136] At time t3, the injury continued, but the amount of liquid in the intercellular spaces decreased due to mechanical pushing as shown in Figure 6C, which reduced the SEM value obtained over the injured area, which reduced the calculated delta value 678 since the SEM value of the healthy tissue remained almost the same as during the previous measurements.

[0137] At time t4, the damage has progressed to the point where it is visible at the skin surface, as shown in FIG. 3A. In some instances, time t4 may occur before one or both of t2 and t3. In some instances, time t4 may occur after the delta value reaches zero again along curve 670 after time t3 and before t5. Arrow 665 indicates that the damage remained visible after time t4. In some instances, the tissue may be considered a "Stage 1" decubitus ulcer after time t4.

[0138] At time t5, the damage had progressed to the point where enough fluid had been pushed out of the local tissue that the SEM value of a measurement made across the damaged area was less than the SEM value of healthy tissue. As shown in FIG. 3B, this resulted in a negative delta value 680. In some instances, a negative delta will indicate that the tissue is severely damaged. In some instances, a negative delta will indicate that a portion of the tissue has died at the location of the lowest SEM value.

[0139] Example 8: Method I for mapping areas of possible damage

[0140] FIG. 7A is an example of how to map areas of possible damage. Damaged area 700 was surrounded by healthy tissue 708. Central area 730 was significantly damaged. A first surrounding area 720 was less damaged, and a second surrounding area 710 was less damaged but still not healthy tissue. The skin covering all of these areas was of similar appearance and texture and did not indicate subsurface damage. A series of dashed circles 740, 742, 744, 746, 748, and 750 show an example set of locations where SEM measurements were taken. SEM measurements taken at locations 740, 742, and 750 generally produced SEM values ​​associated with healthy tissue, identified in this example as "H". SEM measurements taken at locations 744 and 748 generally produced SEM values ​​"J", which were slightly greater than H. SEM measurements taken at location 746 generally produced SEM values ​​"P", which were greater than J. All of these measurements were considered to have been made at a single "location" on the patient's body, e.g., at the sacrum, even though the individual locations were spatially distributed throughout this location. For this set of SEM values, the delta was taken as the difference between the maximum SEM value within the set, which likely occurred at location 746, and the minimum SEM value, which likely occurred at one of locations 740, 742, and 750. If the delta was greater than a threshold "T," this indicated significant damage at this location. The exact location of maximum damage was likely close to measurement location 746, which produced the largest SEM value.

[0141] Example 9: Method for mapping areas of possible damage II

[0142] FIG. 7B shows a second example of mapping the area of ​​possible damage. In this example, the approximate location of the maximum damage was known, for example by a previous application of the method shown in FIG. 7A. The intent of this method was to map the boundary between area 710 and area 720 to determine the extent of the damage. For simplicity, the SEM values ​​generated by the measurements within each area were the same, and the SEM values ​​increased from area 710 to area 720 to area 730. The first SEM measurement was made at location 760, which was known to be the approximate location of the maximum damage. Subsequent measurements were made at locations 762, 764, 766, and 768, in the order shown by path 780. The SEM value generated at location 764 was slightly larger than the SEM values ​​generated at locations 762 and 766, indicating that location 764 was partially within area 720, while locations 762 and 766 were entirely within the less damaged area 710. The boundary could be approximated by interpolating between the various measurement locations. For example, the SEM value generated at location 770 was not useful in identifying the boundary between areas 710 and 720 because it was large enough to suggest that it was entirely within area 720. Thus, the subsequent location 772 was quite far from the starting location 760. Since location 760 in this example is now entirely within area 710, the boundary between areas 710 and 720 could be interpolated as being between locations 770 and 772. Since the SEM value generated by the measurement at location 774 was similar to the SEM value from location 770, it could be sufficient to identify the boundary as being outside location 774 without making another measurement at a location equivalent to location 772.

[0143] This set of measurements allows the creation of a map of a particular level of damage, for example area 720. Repeating this mapping process at regular time intervals will provide an indication as to whether area 720 is expanding, which may indicate that an increased level of intervention is appropriate, or whether area 720 is shrinking, which may indicate that the current level of intervention is allowing the damage to heal.

[0144] Example 10: Treatment decision pathways for patient stratification and delivery of appropriate treatment

[0145] Figure 8A outlines the currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients as presented by The National Institute for Health and Care Excellence (NICE) in their clinical guideline Pressure ulcers: prevention and management published on 23 April 2014. The guideline recommended that a risk analysis be performed for every patient admitted to a care facility who presents with one or more risk factors, such as significant restriction of mobility, significant loss of sensation, previous or current pressure ulcers, nutritional impairment, inability to position themselves, or significant cognitive impairment. Risk assessment is usually performed using a scoring checklist, such as the Braden scale, which assesses the severity of certain risk factors.

[0146] Once the risk assessment is complete, patients are identified as having (i) a 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, patients are classified as having, and are evaluated by various procedural procedures and visual evaluations.

[0147] All patients are potentially at risk for developing pressure ulcers. They are more likely to occur in people who are seriously ill or who have neurological diseases, movement disorders, nutritional disorders, poor posture, or deformities.

[0148] Pressure ulcers are classified into stages 1 to 4, with stage 1 being the least severe. The NPUAP (National Pressure Ulcer Advisory Committee) defines a "stage 1" ulcer as intact skin with a localized area of ​​non-blanchable erythema, where "blanchable" indicates loss of all redness of the tissue when pressure is applied; "non-blanchable" tissue remains red when pressure is applied due to the presence of red blood cells outside of the blood vessels (extravasation). In some patients, the blanchable erythema or changes in sensation, temperature, or consistency may precede visible changes.

[0149] Visual skin assessment (VSA) is the current method for identifying decubitus ulcers. Trained healthcare personnel visually and tactilely assess the appearance of the skin, looking for redness or variations in tissue firmness, tissue temperature or moisture.

[0150] If a patient is identified as being at low risk for developing a pressure ulcer, the patient is simply monitored for changes in clinical status, such as undergoing surgery, worsening of underlying disease, or changes in mobility. Patients who use a wheelchair or are sedentary for extended periods of time may be given a high performance foam cushion or equivalent pressure relieving cushion. If there is no change in clinical status, low risk patients will not be reassessed under this set of guidance and will remain on the same treatment and evaluation pathway until they leave the care facility.

[0151] If a patient is identified as at risk of developing a pressure ulcer, they will be scheduled to be repositioned, or "turned", every six hours. If the patient is wheelchair bound or seated for long periods, as in the case of low-risk patients, they may be given a high-performance foam cushion. No other monitoring or intervention is recommended by the NICE guidelines.

[0152] High-risk patients will be given a high-performance foam mattress as a preventative measure, a high-performance cushion if they are wheelchair bound or seated for extended periods, and will be turned every 4 hours. Patients will undergo daily VSA on all areas of the body. If areas with non-blanching erythema are found, appropriate interventions will be implemented and the area will be rechecked with VSA every 2 hours. Areas not showing non-blanching erythema will be rechecked with VSA daily. An individualized care plan will be developed for each high-risk patient.

[0153] From this flow chart, it can be seen that the majority of the caregiver's time will be with high-risk patients. While this may be appropriate, at-risk patients will remain unmonitored and may develop stage 1 ulcers before symptoms are observed by the caregiver. Furthermore, the result of relying on VSA to detect problems will inevitably mean that patients will develop stage 1 ulcers before intervention is selected or implemented. By the time damage progresses to stage 1, it is likely that the skin will break down and become a stage 2 ulcer despite intervention. There is a clear need to identify tissue damage earlier so that intervention can prevent subepidermal damage from progressing to stage 1 and beyond.

[0154] FIG. 8B is an example of a current expanded treatment decision pathway for pressure ulcer prevention currently implemented in some healthcare facilities. The expanded pathway adds a monitoring step to both at-risk and low-risk pathways. Low-risk patients undergo a weekly risk assessment, e.g., Braden Scale assessment is performed. Patients identified as at-risk at initial assessment will be given a high-performance foam mattress as a preventative measure and will be evaluated daily with a VSA. A care plan will be developed to monitor and treat the at-risk patient. For high-risk patients, there will be no change in care.

[0155] The expanded plan has the advantage of providing baseline monitoring of all patients for decubitus ulcers; however, the additional steps require additional time by adding staff and placing additional strain on existing staff. Although the care pathway in Figure 8B is superior to the recommended care pathway in Figure 8A, it requires more resources and still suffers from the limitation that patients must develop a stage 1 ulcer before injury can be identified with VSA.

[0156] Various hospitals and nursing facilities use a variety of numbers of risk categories, ranging from two categories, low risk and at risk, to four or more categories, such as "very high risk," in addition to the categories in the example of Figure 8B. Patients are assigned to various categories based on the results of their initial risk assessment.

[0157] FIG. 9 is an example flow chart of how the SEM scanner may be used in a stand-alone decubitus ulcer prevention treatment according to the present disclosure. All incoming patients undergo a complete SEM scanner evaluation of all body locations selected for monitoring. These selected locations may include areas recommended in the SEM scanner Instructions for Use (IFU), such as the sacrum and both heels. Additional locations may be identified by the hospital and integrated into practice within the hospital. Multiple SEM measurements are taken at and around each body location at locations spaced apart from one another, generally referred to as taking multiple measurements at a body location. A "delta" value is calculated for each location from the set of measurements taken at and around the location by the SEM scanner. The delta value is then compared to one or more thresholds to classify the patient. In this example, patients are assigned to one of two risk categories: low risk and at risk.

[0158] In one aspect, the clinician will perform SEM scans of the body locations identified in the initial SEM scan as having possible damage at a first time interval. The clinician will also perform SEM scans of all other body locations selected for monitoring at a second time interval that is longer than the first time interval. In one aspect, the values ​​of the first and second time intervals depend on the risk classification to which the patient is assigned. For example, a high-risk patient will have a first time interval of 4 hours and a second time interval of 1 day, while an at-risk patient will have a first time interval of 1 day and a second time interval of 1 week. In one aspect, the time intervals may not be strictly time-based, but event-based, such as when personnel are changed or shifts are changed. Generally, body locations with high delta values ​​are scanned more frequently than other body locations that are monitored but had normal delta values ​​in previous SEM scans.

[0159] In one aspect, the interval at which SEM scans are performed is determined by the delta value from the previous SEM scan, for example, if a SEM scan of a body location had a delta value equal to or greater than a first threshold in the previous SEM scan, then the SEM scan is performed at a first time interval, while if a previous SEM scan of a body location had a delta value equal to or greater than a second threshold that is greater than the first threshold, then the SEM scan is performed at a second time interval that is shorter than the first time interval.

[0160] In this example, low-risk patients undergo weekly SEM scans of all body locations selected for monitoring. This is a small effort that provides basic protection for even the healthiest patients, as weekly SEM scans are more likely to detect tissue damage before it becomes visible on the VSA.

[0161] At-risk patients, which would include patients who would be identified as high risk in the current care pathways of Figures 8A and 8B, would receive specialized care based on the body locations exhibiting delta values ​​above a threshold. For example, if the sacral body location has a delta value above a threshold, the patient would be turned every 6 hours and receive daily SEM scans of the sacrum and weekly SEM scans of other body locations.

[0162] 10 is an example flow chart of how a SEM scanner may be used as an aid to further refine the expanded treatment decision pathway of FIG. 8B in accordance with the present disclosure. Incoming patients undergo both a risk assessment and an SEM scan of all body locations identified by the hospital for monitoring, and the assignment of the patient to a risk category is based in part on the risk assessment and in part on the SEM scan results. An initial delta value greater than a threshold indicates possible damage at that body location. In some aspects, the assignment is based solely on the largest initial delta value found during the initial SEM scan.

[0163] The decision to perform an intervention, such as repositioning the patient at a first interval, is currently based on the VSA and risk assessment, despite the uncertainty of whether there is early stage damage subcutaneously. In one aspect, the decision to perform an intervention at a particular body location or a conventional intervention, such as a smart mattress, is based on the delta value revealed at that location in the SEM scan. If the delta value is less than a predetermined threshold, no intervention is necessary. If the delta value is greater than a predetermined threshold, then an intervention is selected and performed based in part on the body location and in part on the delta value at that body location. The predetermined threshold for whether to select and perform an intervention may be greater or less than the threshold for determining whether there is potential damage at a body location.

[0164] A comparison of the costs of providing the care pathways of Figures 8A, 8B, 9 and 10 highlights one advantage of utilizing an SEM scanner to monitor patients. Note that the costs quoted herein are for patients who do not have or have not developed decubitus ulcers, where expected treatment costs rise to $2000 for stage 1 ulcers.

[0165] The baseline for this comparison is the expanded current practice in Figure 8B, which represents the current "best practice" for hospitals seeking to reduce the incidence of pressure ulcers. Providing care for the low-risk care pathway is expected to cost an average of $26 per patient for an average length of stay of 5.6 days, care for at-risk patients is expected to cost an average of $121, and high-risk patients are expected to cost $165. All of the care pathways rely on VSA to detect pressure ulcers and otherwise implement interventions based on "typical" patient progression rather than specific patient symptoms.

[0166] As shown in Figure 10, integrating an SEM scanner into the current “best practice” workflow does not lower the cost of any of the care pathways since no work elements are eliminated. The benefit is the ability to detect tissue damage at an earlier stage with minimal incremental cost. The incremental cost of adding an SEM scan to a no-risk care pathway is $2, raising the cost from approximately $26 to $28. The expected cost of care for at-risk patients who do not have a high delta value for the SEM scan, i.e., do not have subepidermal tissue damage, also increases by $2. However, if an at-risk patient is found to have a high delta value for the SEM scan, the patient will move up to the high-risk category, where the expected cost of care will increase from $165 to $169. While this may seem like an additional cost at first glance, it represents an increased level of protection provided to at-risk patients.

[0167] Figure 9 depicts an example workflow that relies solely on the SEM scanner to monitor patients, without routine VSA. The expected cost of preventative care for low-risk patients is $4, compared to a cost of $28 for the integrated low-risk care pathway of Figure 10. For at-risk patients who are simply another classification for the SEM scanner care pathway of Figure 9, the expected cost is $97, compared to $123 to $169 for at-risk and high-risk patients for the integrated care pathway of Figure 10.

[0168] From the foregoing description, it will be appreciated that the present disclosure can be embodied in a variety of ways, including but not limited to the following:

[0169] Embodiment 1. A method for identifying and treating a patient in need of treatment for a pressure ulcer, comprising: assessing the patient for the patient's risk of a pressure ulcer upon admission to a care facility, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a level-0 first intervention if the first delta value does not exceed the first threshold; and administering a level-N first intervention if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1.

[0170] Embodiment 2. The method of embodiment 1, wherein the step of performing a first plurality of SEM measurements includes performing each SEM measurement using an SEM scanner to generate a respective SEM value, and the step of calculating the first delta value includes comparing SEM values ​​generated by a portion of the first plurality of SEM measurements.

[0171] Embodiment 3. The step of performing a first plurality of SEM measurements includes performing a first subset SEM measurement at a first location and at least one further subset SEM measurement at a second location, the step of calculating a first delta value includes calculating a first delta value at the first location from a portion of the measurements of the first subset and calculating a first delta value at the second location from a portion of the measurements of the second subset, and the step of determining whether the first delta value exceeds a first threshold includes determining whether the first delta value at the first location exceeds a first threshold at the first location and determining whether the first delta value at the second location exceeds a first threshold at the second location. The method of embodiment 1, wherein the step of administering the level-0 first intervention includes administering a level-0 intervention specific to the first location if the first delta of the first location does not exceed a first threshold of the first location, and administering a level-0 intervention specific to the second location if the first delta of the second location does not exceed a first threshold of the second location, and the step of administering the level-N first intervention includes administering a level-N intervention specific to the first location if the first delta of the first location exceeds a first threshold of the first location, and administering a level-N intervention specific to the second location if the first delta of the second location exceeds a first threshold of the second location.

[0172] Embodiment 4. The method of embodiment 1, wherein the evaluating step further comprises performing a visual evaluation.

[0173] Embodiment 5. The method of embodiment 4, wherein the patient has no visible signs of a decubitus ulcer.

[0174] Embodiment 6. The method of embodiment 1, wherein the evaluating step further comprises performing a risk assessment.

[0175] Embodiment 7. The method of embodiment 1, wherein N has a value equal to 1.

[0176] Embodiment 8. The method of embodiment 1, wherein the value of N is 2 or greater based on the amount by which the first delta value exceeds the first threshold.

[0177] Embodiment 9. The method of embodiment 1, wherein N is a value not exceeding 10.

[0178] Embodiment 10. The method of embodiment 1, wherein the first intervention at Level-N is a more effective intervention than the first intervention at Level-0.

[0179] Embodiment 11. The method of embodiment 1, further comprising the steps of: performing a second plurality of SEM measurements on the patient at a first predetermined frequency corresponding to a level of intervention to be administered; calculating a second delta value from a portion of the second plurality of SEM measurements; determining whether the second delta value exceeds a second threshold; continuing to administer the first intervention if the second delta value does not exceed the second threshold; continuing to perform the plurality of SEM measurements at the first predetermined frequency if the second delta value does not exceed the second threshold; administering a second intervention at level-M if the second delta value exceeds the second threshold, where M is an integer and M is greater than N; and performing the plurality of SEM measurements at the second predetermined frequency corresponding to level-M if the second delta value exceeds the second threshold.

[0180] Embodiment 12. The method of embodiment 11, wherein the second threshold is the same as the first threshold.

[0181] Embodiment 13. The method of embodiment 11, wherein the second threshold is greater than the first threshold.

[0182] Embodiment 14. The method of embodiment 11, wherein M has a value equal to N+1 but not greater than 10.

[0183] Embodiment 15. The method of embodiment 11, wherein the value of M is proportional to the amount by which the second delta value exceeds the second threshold.

[0184] Embodiment 16. The method of embodiment 11, further comprising the steps of determining whether the second delta value is less than a third threshold, administering a level-(N-1) intervention if the second delta value is less than the third threshold and if the first intervention is not level-0, and taking multiple SEM measurements at a predetermined frequency corresponding to level-(N-1) if the second delta value is less than the third threshold.

[0185] Embodiment 17. The method of embodiment 1, wherein the Level-0 intervention is selected from the group consisting of providing good nutrition, a standard mattress, repositioning every 24 hours, and combinations thereof.

[0186] Embodiment 18. The method of embodiment 1, wherein the first delta value exceeding the first threshold is calculated from a portion of a first plurality of SEM measurements taken at the patient's heel.

[0187] Embodiment 19. The method of embodiment 18, wherein the level-1 intervention is providing the patient with a heeled boot.

[0188] Embodiment 20. The method of embodiment 18, wherein the level-2 intervention is to change the patient's support surface.

[0189] Embodiment 21. The method of embodiment 18, wherein the level-3 intervention is to apply a dressing to the posterior or lateral side of the patient's heel.

[0190] Embodiment 22. The method of embodiment 18, wherein the level-4 intervention is changing the patient's seat cover to a low friction seat cover.

[0191] Embodiment 23. The method of embodiment 18, wherein the level-5 intervention is to provide a low-friction padded mattress surface against the patient's lower legs.

[0192] Embodiment 24. The method of embodiment 18, wherein the level-6 intervention is to reposition the patient at shorter intervals than currently provided.

[0193] Embodiment 25. The method of embodiment 18, wherein the level-7 intervention is applying a protective cream to the patient's heels.

[0194] Embodiment 26. The method of embodiment 18, wherein the level-8 intervention is administering neuromuscular stimulation to the patient's heel.

[0195] Embodiment 27. The method of embodiment 18, wherein the level-9 intervention is applying a topical cream to the patient's heel to increase perfusion.

[0196] Embodiment 28. The method of embodiment 18, wherein the level-10 intervention is providing silicone pads to the patient's lower legs.

[0197] Embodiment 29. The method of embodiment 1, wherein the first delta value exceeding the first threshold is calculated from a portion of a first plurality of SEM measurements taken at the patient's sacrum.

[0198] Embodiment 30. The method of embodiment 29, wherein the level-1 intervention is selected from the group consisting of repositioning the patient with a wedge, keeping the patient's sacrum dry, and combinations thereof.

[0199] Embodiment 31. The method of embodiment 29, wherein the level-2 intervention is changing the patient's mattress to a pressure-relieving mattress.

[0200] Embodiment 32. The method of embodiment 29, wherein the level-3 intervention is applying a dressing over the patient's sacrum.

[0201] Embodiment 33. The method of embodiment 29, wherein the level-4 intervention is changing the patient's mattress to a dynamic mattress.

[0202] Embodiment 34. The method of embodiment 29, wherein the level-5 intervention is applying a protective cream to the patient's sacrum.

[0203] Embodiment 35. The method of embodiment 29, wherein the level-6 intervention is to apply neuromuscular stimulation to the patient's sacrum.

[0204] Embodiment 36. The method of embodiment 29, wherein the level-7 intervention is applying a topical cream to the patient's sacrum to increase perfusion.

[0205] Embodiment 37. The method of embodiment 29, wherein the level-8 intervention is providing a silicone pad under the patient's body.

[0206] Embodiment 38. The method of embodiment 1, wherein the predetermined frequency of level-0 is every 24 hours.

[0207] Embodiment 39. The method of embodiment 1, wherein the predetermined frequency of level-1 is every 10 hours.

[0208] Embodiment 40. The method of embodiment 1, wherein the predetermined frequency of Level-2 is at the beginning of each nursing shift.

[0209] Embodiment 41. The method of embodiment 1, wherein the predetermined frequency of level-3 is every 12 hours.

[0210] Embodiment 42. The method of embodiment 1, wherein the predetermined frequency of level-4 is every 8 hours.

[0211] Embodiment 43. The method of embodiment 1, wherein the predetermined frequency of level-5 is every 6 hours.

[0212] Embodiment 44. The method of embodiment 1, wherein the predetermined frequency of level-6 is every 4 hours.

[0213] Embodiment 45. The method of embodiment 1, wherein the predetermined frequency of level-7 is every two hours.

[0214] Embodiment 46. The method of embodiment 1, wherein the predetermined frequency of level-8 is every hour.

[0215] Embodiment 47. The method of embodiment 1, wherein the predetermined frequency of level-9 is every 0.5 hours.

[0216] Embodiment 48. A method for slowing the progression of development of a pressure ulcer in a patient in need thereof, comprising the steps of: identifying a current intervention at level-K received by the patient; taking a plurality of subepidermal moisture (SEM) measurements on the patient; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a first threshold; continuing to administer the current intervention if the delta value does not exceed the first threshold; continuing to take the plurality of SEM measurements at a predetermined frequency corresponding to level-K if the delta value does not exceed the first threshold; administering a new intervention at level-N if the delta value exceeds the first threshold, where N has a value greater than K; and administering the new intervention at level-N if the delta value exceeds the first threshold; and taking the plurality of SEM measurements at a predetermined frequency corresponding to level-N if the delta value exceeds the first threshold.

[0217] Embodiment 49. The method of embodiment 48, wherein N is equal to K+1 but does not exceed 10.

[0218] Embodiment 50. The method of embodiment 48, wherein the value of N is proportional to the amount by which the delta value exceeds the first threshold.

[0219] Embodiment 51. The method of embodiment 48, further comprising the steps of determining whether the delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and performing a plurality of SEM measurements at a predetermined frequency corresponding to level-L if the delta value is less than the second threshold.

[0220] Embodiment 52. The method of embodiment 51, wherein L has a value equal to L-1.

[0221] Embodiment 53. The method of embodiment 51, wherein the value of L is selected based on the amount by which the delta value falls below a second threshold.

[0222] Embodiment 54. The method of embodiment 48, wherein the patient in need thereof is a patient undergoing a change in care.

[0223] Embodiment 55. The method of embodiment 48, wherein the patient in need thereof is a patient experiencing altered mobility.

[0224] Embodiment 56. The method of embodiment 48, wherein the patient in need thereof is a patient undergoing nutritional alterations.

[0225] Embodiment 57. The method of embodiment 48, wherein the patient in need thereof is a patient experiencing altered sensory perception.

[0226] Embodiment 58. The method of embodiment 48, wherein the patient in need thereof is a patient suffering from an open ulcer.

[0227] Embodiment 59. The method of embodiment 48, wherein the patient in need thereof is a patient with a healing open ulcer.

[0228] Embodiment 60. The method of embodiment 48, wherein the patient in need thereof is a patient undergoing surgery.

[0229] Embodiment 61. The method of embodiment 48, wherein the patient receives spinal anesthesia during surgery.

[0230] Embodiment 62. The method of embodiment 60, wherein the patient receives sacral anesthesia during surgery.

[0231] Embodiment 63. The method of embodiment 60, wherein the surgical procedure lasts for 4 hours or more.

[0232] Embodiment 64. A method of selecting a treatment for a pressure ulcer for a patient, comprising: assessing the patient for the patient's risk of a pressure ulcer upon admission to a care facility, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a first intervention at level-0 if the first delta value does not exceed the first threshold; and administering a first intervention at level-N if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1.

[0233] Embodiment 65. A method for stratifying groups of patients in a care facility based on risk of pressure ulcers, comprising the steps of: taking a plurality of subepidermal moisture (SEM) measurements for each patient; calculating a delta value from a portion of the plurality of SEM measurements for each patient; assigning a level of care to each patient based on whether each delta value exceeds any value in a set of thresholds corresponding to N levels of care; and reorganizing the patient groups based on each of the levels of care assigned to the patients.

[0234] Embodiment 66. A method for reducing the incidence of pressure ulcers in patients admitted to a nursing home, comprising: assessing the patient for pressure ulcer risk upon admission to the nursing home, the assessing step including taking a first plurality of subepidermal moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first plurality of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a level-0 first intervention if the first delta value does not exceed the first threshold; and administering a level-N first intervention if the first delta value exceeds the first threshold, where N is an integer and N has a value greater than or equal to 1.

[0235] Embodiment 67. The method of embodiment 66, wherein the incidence of ulcers in patients in a nursing home is reduced to 1 in 100.

[0236] Embodiment 68. A method for identifying and treating a patient in need of application of a protective cream to the patient's heel, comprising the steps of taking a plurality of subepidermal moisture (SEM) measurements on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to a level N, where N is greater than or equal to 2, applying a protective cream to the patient's heel if the delta value exceeds the threshold, and taking a plurality of SEM measurements every two hours if the delta value exceeds the threshold.

[0237] Embodiment 69. A method for identifying and treating a patient in need of neuromuscular stimulation to the patient's heel, comprising the steps of: taking a plurality of subepidermal moisture (SEM) measurements at the patient's heel; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a threshold corresponding to a level N, where N is greater than or equal to 2; administering neuromuscular stimulation to the patient's heel if the delta value exceeds the threshold; and taking a plurality of SEM measurements every hour if the delta value exceeds the threshold.

[0238] Embodiment 70. A method for identifying and treating a patient in need of application of a topical cream to the patient's heel, comprising the steps of taking a plurality of subepidermal moisture (SEM) measurements on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to a level N, where N is greater than or equal to 2, applying a topical cream to the patient's heel if the delta value exceeds the threshold, and taking a plurality of SEM measurements every 30 minutes if the delta value exceeds the threshold.

[0239] Embodiment 71. A method for identifying and treating a patient in need of application of a protective cream to the patient's sacrum, comprising the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to a level N, where N is 2 or greater, applying a protective cream to the patient's sacrum if the delta value exceeds the threshold, and taking a plurality of SEM measurements every 6 hours if the delta value exceeds the threshold.

[0240] Embodiment 72. A method for identifying and treating a patient in need of neuromuscular stimulation to the patient's sacrum, comprising the steps of: taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a threshold value corresponding to a level N, where N is greater than or equal to 2; administering neuromuscular stimulation to the patient's sacrum if the delta value exceeds the threshold value; and taking a plurality of SEM measurements every four hours if the delta value exceeds the threshold value.

[0241] Embodiment 73. A method for identifying and treating a patient in need of application of a topical cream to the patient's sacrum, comprising the steps of taking a plurality of subepidermal moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold value corresponding to a level N, where N is 2 or greater, applying a topical cream to the patient's sacrum if the delta value exceeds the threshold value, and taking a plurality of SEM measurements every two hours if the delta value exceeds the threshold value.

[0242] While the present disclosure has been described with respect to particular aspects, those skilled in the art will recognize that various modifications may be made and equivalents may be substituted for the elements thereof without departing from the scope of the disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from its scope. Therefore, the disclosure is not intended to be limited to the particular aspects disclosed, but it is intended that the disclosure include all aspects falling within the scope and spirit of the appended claims.

Claims

1. 1. A method of evaluating a patient, comprising: performing an initial SEM scan of a body location selected for monitoring; and assigning the patient to a risk category selected from a group including a plurality of risk categories, the assignment being based in part on the initial SEM scan of the body location.

2. 2. The method of claim 1, further comprising the steps of: calculating an initial delta value for the body location from the initial SEM scan; and determining that potential damage is present at the body location if the initial delta value is greater than a first threshold.

3. The method of claim 2 , wherein the step of assigning the patient to a risk category is based in part on the initial delta value.

4. The method of claim 2 , further comprising the step of not implementing the intervention if the delta value is less than a second threshold.

5. The method of claim 2 , further comprising implementing an intervention if the delta value is greater than or equal to a second threshold.

6. The method of claim 5 , wherein the intervention is selected based in part on the body location and in part on the delta value.

7. 7. The method of claim 6, wherein the intervention is selected from the group including a standard mattress, a high performance mattress, a low friction seat cover, a low friction padded mattress surface, a silicone pad, a dressing, a heel boot, a barrier cream, a topical cream to enhance irrigation, repositioning the patient at a first interval, and repositioning the patient at a second interval shorter than the first interval.

8. performing, at a first time interval, a SEM scan of the body locations identified in the initial SEM scan as having possible damage; performing a SEM scan of all body locations selected for monitoring at a second time interval that is longer than the first time interval; The method of claim 1 , further comprising the step of calculating a delta value for each of the SEM scans.

9. The method of claim 8 , wherein the first time interval and the second time interval are dependent on the assigned risk classification.

10. The method of claim 8 , further comprising not performing an intervention on body locations having a delta value that is less than a second threshold.

11. 10. The method of claim 8, further comprising the step of: implementing an intervention for body locations having delta values ​​that are greater than or equal to a second threshold.

12. 2. The method of claim 1, further comprising the steps of: calculating a delta value for a previous SEM scan to establish a first threshold; performing SEM scans of body locations that had delta values ​​in the previous SEM scans that were equal to or greater than the first threshold at a first time interval; and performing SEM scans of body locations that had delta values ​​in the previous SEM scans that were equal to or greater than a second threshold, the second time interval being shorter than the first time interval.

13. The method of claim 1 , wherein the group of risk categories comprises a low risk category and an at-risk category.

14. The method of claim 13 , wherein the group of risk classifications further comprises a high risk classification.

15. performing an initial SEM scan includes performing an initial risk assessment of the patient; The method of claim 1 , wherein the selection of the risk classification is based in part on the results of the initial risk assessment.

16. 1. A method of managing patient care, comprising: Upon admission, performing an initial assessment of said patient and an initial SEM scan of all body locations selected for monitoring; calculating an initial delta value for each body location selected for monitoring; determining that the patient is deviant if any initial delta value is equal to or greater than a first threshold and setting an intervention level N=1; implementing a Level-N intervention for each body location having a delta value equal to or greater than the first threshold; and performing an SEM scan of all body locations at a frequency of Level-N to calculate new delta values.

17. 17. The method of claim 16, further comprising increasing an intervention level from N to N+1, performing the N+1 intervention, and performing SEM scans at the same body location at a frequency of N+1 if any new delta values ​​are greater than or equal to the previous delta values.

18. 17. The method of claim 16, further comprising the step of continuing with N interventions and performing SEM scans at N frequencies if all new delta values ​​above the first threshold are less than their respective previous delta values ​​at the same body location.

19. 17. The method of claim 16, further comprising the step of performing SEM scans at a frequency of N-1 if all of the new delta values ​​are less than a second threshold that is less than the first threshold.

20. When a patient is transferred or discharged, 17. The method of claim 16, further comprising the steps of: performing a final set of SEM scans of all body locations selected for monitoring; calculating a final set of delta values ​​for each scanned body location; and documenting the final set of delta values.

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