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

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.

Conditions

• Nonsuicidal Self Injury
• Stigmatization
• Cicatrix
• Skin Transplantations

Interventions

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.

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim

  collaborator OTHER

• Berufsgenossenschaftliche Unfallklinik Ludwigshafen

  lead OTHER

Principal Investigators

• Dimitra Kotsougiani-Fischer, MD · Senior

• Ulrich Kneser, MD · chief of department

• Julian Vogelpohl, MD · Senior

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-06

Primary Completion

2022-11-30

Completion

2024-11-30

FDA Device

Yes

Countries

• Germany

Study Locations