NCT04420442

Scar Resection and Reconstruction With Integra and Split Skin Grafts in Patients With Non-Suicidal Self-Inflicted Scars

Influence of Surgical Scar Resection, Followed by Reconstruction With Integra and Split Skin Grafts on Quality of Life, Body Perception, Scar Perception and Stigmatization in Patients With Non-Suicidal Self-Inflicted Scars

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Berufsgenossenschaftliche Unfallklinik Ludwigshafen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Non-suicidal self-inflicted (NSSI) scars can act as a physical reminder of previous self-inflicted self-harm, thereby not only worsening the symptoms of depression and self-doubt but also leading to recurrent self-infliction and social exclusion. Several different treatment options exist to alter the appearance of NSSI scars like pulsed-dye laser therapy (PDL), non-ablative fractional laser therapy, dermabrasion or elliptical excision. However, none of these treatment options can completely diminish the scars. In the majority of cases, the unique scar pattern of NSSI scars and in addition to that the "reminder" remains. In contrast to regular scar revisions, the aesthetical appearance is not the most important outcome parameter as the main focus of the surgical treatment is destigmatization. The surgical transformation of the scar into a burn-like scar could change the scar-perception of the society and the patient, thereby improving the patient's quality of life and body perception. Surgical resection with preservation of the subcutaneous tissue followed by consecutive reconstruction with a bilayer dermal regenerative matrix (IntegraTM) and split skin grafts might represent a promising and novel therapeutic approach. The hypothesis is that by surgically transforming the non-suicidal self-inflicted scars into a burn-like scar the patient's body and scar perception will be positively altered and the stigmatization by the society reduced.

Detailed description

Non-suicidal self-injury behaviour describes behaviour in patients, who have no intention to commit suicide. This can be performed in many different ways, e.g., automutilation through burning, scratching, or hitting. Often this behaviour results in deep scars and disfigurements. The prevalence of patients with NSSI scars is estimated to be 13.4% in adolescents and 5.5% in adults. Non-suicidal behaviour is often associated with other psychological diseases like personality disorders, character disorders of the Borderline type, anxiety, and substance abuse disorders. In these cases, usually, interdisciplinary therapy concepts are needed. A major problem is that the scars due to its constant confrontation can induce repetitive non-suicidal self-injury behaviour. Furthermore, the image of the NSSI scars leads to stigmatization by society and in addition to that to a withdrawal from society by the patients. Hence, the need for adequate treatment of the NSSI scars to relief the burden of stigmatization for the patients is immense. At the moment, non-invasive therapies like pulsed-dye laser therapy (PDL) and non-ablative fractional laser therapy, as well as minimal-invasive therapies like dermabrasion or elliptical excision offer one possible option, but the undoubted cause of the scar remains visible. At the moment only case studies exist which describe the beneficial effect of surgical resection followed by consecutive reconstruction with a dermal regenerative matrix and split skin grafts. These studies have evaluated the aesthetic outcome and briefly assessed the well-being of the patients. However, currently, no study exists investigating the effect of the two-step surgical procedure on body perception and the psychological outcome in general. The overall goal of the described study is to establish a therapy concept for patients who suffer from constant confrontation with their NSSI scars. Stigmatization by the society and by the patients themselves, body perception, quality of life, and scar perception will be evaluated over the study period of 36 months. Furthermore, the scar itself will be assessed using a cutometer and the scar image will be evaluated using the Patient and Observer Scar Assessment Scale. The data analyses will be performed with SPSS, version 20.0, SPSS Inc. Chicago, USA. For the normally distributed values, the paired T-test will be used. Not normally distributed values will be analysed by the Wilcoxon signed-rank Test. The significance level will be set at p\<0.05.

Conditions

• Nonsuicidal Self Injury
• Stigmatization
• Cicatrix
• Skin Transplantations

Interventions

Type	Name	Description
PROCEDURE	Scar Transformation Group	Surgical excision of the NSSI scars followed by IntegraTM transplantation and wound closure with a negative pressure wound system. After 21 days the silicone layer of the IntegraTM will be removed and split thickness skin will be transplanted. After suture removal a compression therapy by individually tailored garments will be started for 12 months.

Timeline

• Start date: 2018-11-06
• Primary completion: 2022-11-01
• Completion: 2024-11-01
• First posted: 2020-06-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study