Method for treating hypertrophic postoperative scars using capacitive-resistive electrical energy transfer device

Abstract

FIELD: plastic surgery.SUBSTANCE: used to treat hypertrophic postoperative scars. Scars are classified according to stages of development. In this case, forming ones – from 1 to 14 days after surgery, fresh ones – from 15 days to 3 months, maturing ones – from 3 months 1 day to 12 months, mature ones – more than 12 months. An appropriate therapy protocol is selected, consisting of a course of 6 to 16 procedures with a frequency of 2–3 times a week using the INDIBA Elite NS hyperthermic radiofrequency device and two types of electrodes – capacitive CAP and resistive RES, while the intensity of exposure is regulated by a 10-point scale of subjective sensations of heat by the patient.EFFECT: method allows for the normalization of histoarchitecture, increased elasticity, and regression of hypertrophic postoperative scars through differentiated high-frequency thermal action using capacitive and resistive electrodes, the parameters of which are strictly adapted to the specific stage of connective tissue maturation.1 cl, 4 dwgs, 1 tbls, 2 ex

Description

[0001] A hypertrophic scar is a dense connective tissue formation that occurs as a result of tissue regeneration following injury or inflammation due to excessive connective tissue formation during wound healing. Hypertrophic scars are exophytic structures associated with significant aesthetic and physical defects for patients. The presence of a scar is often accompanied by subjective sensations such as discomfort, paresthesia, pain upon palpation, contact with clothing, as well as a feeling of tightness, tension, and itching.

[0002] • L91.0 Hypertrophic scar Novelty:

[0003] 1. This is a proposed treatment method for patients with hypertrophic postoperative scars. A hypertrophic scar (L91.0) is a dense connective tissue formation that occurs as a result of tissue regeneration following injury or inflammation due to excessive connective tissue formation during wound healing. Hypertrophic scars are exophytic structures associated with significant aesthetic and physical defects for patients. The presence of a scar is often accompanied by subjective sensations such as discomfort, paresthesia, pain upon palpation, contact with clothing, as well as a feeling of tightness, tension, and itching.

[0004] Currently, various conservative approaches are used to prevent postoperative hypertrophic scars, including topical medications, pressure therapy, silicone sheets, and gels. The disadvantages of these methods include the long course of therapy for these patients with a weak clinical effect. Various treatment methods for patients with hypertrophic scars have also been described to date, including phototherapy, radiation therapy, cryotherapy, photothermolysis, laser therapy, needle radiofrequency therapy, surgical excision, and intralesional injections (glucocorticosteroids, chemotherapeutic agents, botulinum neuroprotein type A, and interferons). Disadvantages of these methods include significant pain and discomfort during the procedures, a recovery period, and the impossibility of using them or their insufficient effectiveness in preventing pathological scar formation in the early stages.The technical problem that the claimed invention is aimed at solving is the creation of a new method for treating postoperative hypertrophic scars that does not have the above-mentioned disadvantages.

[0005] Physiotherapeutic treatment of postoperative hypertrophic scars using the INDIBA Elite NS hyperthermic radiofrequency device has several advantages over the technologies described above: this method is painless and comfortable; there is no recovery period; the method is non-invasive; it provides a personalized approach based on the patient's subjective perception of thermal sensations; the method allows for an optimal combination of both capacitive and resistive effects on the affected tissue; the use of this method is effective for both the prevention and treatment of postoperative hypertrophic scars at any stage of cicatricial deformity formation. This method is aimed at correcting cicatricial deformity taking into account the patient's condition, while allowing for the adaptation of therapy depending on the dynamics of the cicatricial lesion and individual tolerance of the procedure at the time of its implementation.

[0006] The technical result of the claimed invention consists in the prevention and treatment of pathological scarring by stimulating tissue reparation and reducing the severity of fibrosis at the site of invasive intervention.

[0007] 2. A classification of postoperative scars is proposed depending on the degree of formation of cicatricial deformation, as well as its duration of existence after the moment of invasion.

[0008] Description.

[0009] The proposed treatment method involves prescribing therapy to patients with hypertrophic postsurgical scars in the early and / or late stages using the INDIBA Elite NS hyperthermic radiofrequency device (RU dated February 9, 2021, No. RZN 2021 / 13438) to target the area of ​​developing scar deformity or established fibrosis. Physiotherapy treatment with the hyperthermic radiofrequency device is prescribed in courses of 6 to 16 sessions, twice or three times a week, depending on the clinical presentation of the scar deformity and the progression of the condition. The procedure is carried out using a conductive cream, while for the forming scars a sterile conductive cream is used (added to align with the formula), a capacitive "SAR" electrode and a resistive "RES" electrode (Appendix to the RU dated February 9, 2021 No. RZN 2021 / 13438).The intensity of the effect during the procedure is determined based on the patient’s subjective sensation of heat and is assessed using a 10-point scale “IAS” (INDIBA Analogic Scale), where 1 point indicates a feeling of coolness, 5 points indicates a feeling of comfortable warmth, and 10 points indicates a feeling of scorching heat.

[0010] The intensity and duration of exposure are selected based on the diagnosis of the lesion type. It is proposed to determine the lesion type according to the proposed classification of postoperative scars:

[0011] - the forming scar is determined by the period of existence from 1 to 14 days inclusive;

[0012] - a fresh scar is defined as a lifespan of 15 to 90 days inclusive;

[0013] - a maturing scar is defined by a period of existence from 91 days to 12 months inclusive;

[0014] - a mature scar is defined as one that has existed for more than 12 months after surgery.

[0015] Thus, based on the differential diagnosis and determination of the type of lesion, a therapeutic protocol is selected from the proposed ones:

[0016] 1) For developing scars: Stage 1 - exposure using a capacitive "SAR" electrode for 10 minutes, intensity on the "IAS" scale of 1-2 points, using the "continuous modulation" mode and assessing the internal tissue resistance / impedance (I) <100 shA; Stage 2 - exposure using a resistive "RES" electrode for 5 minutes, intensity on the "IAS" scale of 1 point, using the "continuous modulation" mode and assessing the internal tissue resistance / impedance (I) <100 shA. The exposure is carried out on intact areas of the skin at a distance of 0.5-1 cm from the wound defect using a sterile conductive cream.

[0017] 2) For fresh scars: Stage 1 - exposure using a capacitive "CAP" electrode for 10 minutes, intensity on the "IAS" scale of 2-3 points, using the "continuous modulation" mode; Stage 2 - exposure using a resistive "RES" electrode for 5 minutes, intensity on the "IAS" scale of 2-3 points, using the "continuous modulation" mode. Exposure is carried out on intact areas of skin at a distance of 0.5-1 cm from the wound defect, and then on the damaged area after complete epithelialization of the skin defect surface.

[0018] 3) For maturing scars: Stage 1 - exposure using a capacitive "SAR" electrode for 6 minutes, intensity on the "IAS" scale is 4-5 points; Stage 2 - exposure using a resistive "RES" electrode for 6 minutes, intensity on the "IAS" scale is 4-5 points; Stage 3 - exposure using a capacitive "SAR" electrode for 3 minutes, intensity on the "IAS" scale is 2 points.

[0019] 4) For mature scars: Stage 1 - exposure using a capacitive "SAR" electrode for 5 minutes, intensity on the "IAS" scale is 7 points; Stage 2 - exposure using a resistive "RES" electrode for 7 minutes, intensity on the "IAS" scale is 7 points; Stage 3 - exposure using a capacitive "SAR" electrode for 3 minutes, intensity on the "IAS" scale is 2 points.

[0020] Examples

[0021] Thirty patients (L91.0 Hypertrophic Scar - GR) with postoperative hypertrophic scars of various types and complaints of tightness, tension, and discomfort in the affected area underwent a course of 16 sessions using a capacitive-resistive electrical energy transfer device, therapy was performed twice weekly. The age group ranged from 18 to 54 years, and the gender distribution was 9 men and 21 women. All patients had no contraindications to physiotherapy and did not receive additional therapy. Results were assessed one month after completion of therapy using photographic documentation. General clinical examination methods were used, including a general examination with an assessment of the local status and an assessment on the VAS scale.

[0022] VAS - visual analog scale. The effectiveness of the developed method was assessed using the modified VAS scale (objective and subjective symptoms). The following GR parameters were assessed: size, mobility, consistency, erythema, pain, itching, and impact on the patient's daily activities. The objective symptoms were assessed by the researcher (size, mobility, consistency, erythema), while the subjective parameters (pain, itching, impact on the patient's daily activities) were assessed based on the patient's opinion. The patient indicated the severity of the symptom: on a 6-point scale from 0 (no symptom) to 5 (severe symptom). VAS distribution according to the scoring system:

[0023] - size: 0 points - no sign, 1 point - up to 1 cm, 2 points - 1-5 cm, 3 points - 6-10 cm, 4 points - 10-20 cm, 5 points - more than 20 cm;

[0024] - mobility: 0 points - no sign, 1 point - good, 2 points - difficult but possible, 3 points - difficult, 4 points - poor, 5 points - absent;

[0025] - consistency: 0 points - no sign, 1 point - soft, 2 points - slight compaction, 3 points - dense, 4 points - very dense, 5 points - woody;

[0026] - erythema: 0 points - no sign, 1 point - minor, 2 points - mild, 3 points - pronounced but does not affect surrounding tissue, 4 points - pronounced and affects surrounding tissue, 5 points - pronounced with a bluish tint and affects surrounding tissue;

[0027] - pain: 0 points - no symptom, 1 point - mild and intermittent, 2 points - mild and frequent, 3 points - moderate and rare, 4 points - severe and rarely occurring, 5 points - severe and frequently occurring;

[0028] - itching: 0 points - no sign, 1 point - weak and rare, 2 points - weak but periodic, 3 points - strong but rare, 4 points - strong and frequent, 5 points - severe (exhausting) and frequent;

[0029] - impact on the patient's daily activities: 0 points - no impact, 1 point - weak negative impact, 2 points - moderate negative impact, 3 points - strong negative impact, periodically, 4 points - strong negative impact and often, 5 points - pronounced constant negative impact.

[0030] The overall VAS score was determined by adding up all scores for all studied parameters for each patient. The maximum overall VAS score was 35 points, and the minimum was 0 points.

[0031]

[0032] No side effects or complications were observed after the procedure in all 30 patients. Thus, a comprehensive assessment of the dynamics of the VAS index indicates a significant positive impact of capacitive-resistive electrical energy transfer device treatment in the area of ​​hypertrophic scar tissue on the patients' daily functioning. A reduction in size, increased mobility, softening of the scar texture, and a reduction in erythema, pain, and itching in the scar area were achieved, as well as a significant reduction in the negative impact of scar deformities on the patients' daily activities.

[0033] Clinical example No. 1.

[0034] Patient A., 36 years old. Complaints of a linear postoperative scar, discomfort, a feeling of tightness, itching, pain in the area of ​​​​the cicatricial deformity 4 months after surgery, abdominoplasty and surgical correction of a hypertrophic scar in the hypogastric region. The patient did not self-medicate. The anamnesis includes an annual medical examination, during which no diseases were revealed. An allergological history is unremarkable. Upon examination in September 2024, a linear hypertrophic scar of a dense-elastic consistency, crimson in color, with a pronounced vascular component, protruding in relation to the surrounding healthy skin, not extending beyond the original damage, 30 cm long (Fig. 1) was found on the skin in the hypogastric region. Diagnosis: L91.0 Hypertrophic scar. Total VAS - 29 points.

[0035] A course of therapy using the INDIBA Elite NS hyperthermic radiofrequency device was carried out twice a week, No. 16. Each procedure was carried out based on the protocol for managing a "maturing scar": Stage 1 - exposure with a capacitive "SAR" electrode for 6 minutes, intensity according to the "IAS" scale of 4-5 points; Stage 2 - exposure with a resistive "RES" electrode for 6 minutes, intensity according to the "IAS" scale of 4-5 points; Stage 3 - exposure with a capacitive "SAR" electrode for 3 minutes, intensity according to the "IAS" scale of 2 points. A follow-up examination was carried out one month after the treatment.

[0036] During the follow-up examination, the patient's overall well-being improved significantly. No complaints of discomfort, tightness, itching, or pain in the area of ​​the scar deformity were noted. As a result of the treatment, the linear scar on the skin in the hypogastric region is soft and elastic, light pink in color, and does not protrude beyond the surrounding healthy skin or extend beyond the lesion. Significant improvement was noted (Fig. 2). The total VAS score was 12 points.

[0037] Clinical example No. 2.

[0038] Patient B., 54 years old. Complaints of persistent hematomas, compaction, discomfort, a feeling of tightness, tension, and itching in the area of ​​scar deformity 2.5 months after upper and lower eyelid blepharoplasty. No self-medication was attempted. Patient has a history of hypertension and chronic gastritis. Allergy history is unremarkable.Upon examination in October 2024, the skin in the area of ​​the left lower and upper eyelids was found to have dense, elastic, purple-colored linear hypertrophic scars with a pronounced vascular component, protruding in relation to the surrounding healthy skin, not extending beyond the boundaries of the original injury, 0.5 to 2 cm in length; also on the skin in the area of ​​the left lower eyelid along its lateral edge, against the background of a long-term non-resolving hematoma, there was a cicatricial deformation of a dense consistency with purple areas, sharply protruding in relation to the surrounding healthy skin, sharply pulling down the lateral corner of the left eye, measuring 1.5 * 1.0 cm. On the skin in the area of ​​the medial and lateral corner of the left eye there were fibrous cords deforming the palpebral fissure (Fig. 3). Diagnosis: L91.0 Hypertrophic scar. Concomitant diagnosis: L90.5 Scarring and skin fibrosis. Total VAS score: 27 points.

[0039] A course of therapy using the INDIBA Elite NS hyperthermic radiofrequency device was performed twice a week, No. 16. Each procedure was carried out based on the "fresh scar" management protocol: Stage 1 - exposure using a capacitive "SAR" electrode for 10 minutes, intensity on the "IAS" scale of 2-3 points, using the "continuous modulation" mode; Stage 2 - exposure using a resistive "RES" electrode for 5 minutes, intensity on the "IAS" scale of 2-3 points, using the "continuous modulation" mode. A follow-up examination was conducted one month after the treatment.

[0040] During the follow-up examination, the general well-being improved. Complaints of discomfort, a feeling of tightness, itching, or pain in the area of ​​cicatricial deformation were not noted. As a result of the treatment, linear scars on the skin in the area of ​​the left upper and lower eyelids are soft and elastic in consistency, normal in color, do not protrude beyond the surrounding healthy skin, and do not extend beyond the damaged area. An area of ​​fibrosis in the area of ​​the left lower eyelid along its lateral edge has a soft consistency with pink areas, protrudes slightly in relation to the surrounding healthy skin, tension of the lateral corner of the eye is not noted, size 1.5 * 1.0 cm. On the skin in the area of ​​the medial and lateral corner of the left eye, fibrous bands are not noted. Marked positive dynamics are noted (Fig. 4). The total VAS is 10 points.

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