Clinical trial NCT04420442: Scar Resection and Reconstruction With Integra and Split Skin Grafts in Patients With Non-Suicidal Self-Inflicted Scars
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonsuicidal Self Injury
Stigmatization
Cicatrix
Skin Transplantations
Lead sponsor: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Sponsor class: OTHER
Collaborators: name: Central Institute of Mental Health, Mannheim
First posted: 2020-06-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective monocentric non-randomized trial the intervention group and the control will be compared to each other. Furthermore, within the intervention group an intra-individual comparison will be carried out over the study period.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with non-suicidal self-inflicted scars (NSSI) on the forearms who have resigned from self-infliction for more than one year can be included in the study.
* The patients have to be older than 18 years old. Their psychological status has to be stable and certified by a psychologist.
* Patients have to have a high psychosocial pressure due to the non-suicidal self-inflicted scars on the forearms.
* Patients have to agree to supportive psychotherapy during the time of the study.
* Patients have to agree to wear their compression gear for 12 months after the surgical intervention.

Exclusion Criteria:

* Pregnancies
* Age younger than 18
* Any other comorbid conditions like body-dysmorphic conditions or eating disorders
* Tendency to develop hypertrophic scars or keloids
* The participation in other clinical studies.

Primary outcomes:
measure: body perception - Multidimensional Body Self Relations AS Questionnaire
timeFrame: 36 months
measure: scar perception - Patient and Observer Scar Assessment Scale
timeFrame: 36 months
measure: quality of life: SF-36 questionnaire
timeFrame: 36 months
measure: scar perception- Questionnaire for the evaluation of scar perception after burn trauma (FKBB)
timeFrame: 36 months
measure: stigmatization - Self Disgust Scale
timeFrame: 36 months
measure: stigmatization - Self Regret Scale
timeFrame: 36 months
measure: stigmatization - Self-Stigma of Mental Illness Scale (SSMIS-SF)
timeFrame: 36 months
measure: stigmatization - Stigma Stress Scale
timeFrame: 36 months
measure: stigmatization - Disclosure of psychological illness in public and private surroundings - scale
timeFrame: 36 months
measure: stigmatization - Internalized stigma of mental illness inventor (ISMII )
timeFrame: 36 months
measure: stigmatization - Self-labeling and Shame Scale
timeFrame: 36 months
Secondary outcomes:
measure: scar image
timeFrame: 36 months
measure: satisfaction with the aesthetic appearance: non-validated subjective questionnaire
timeFrame: 36 months
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: BG Trauma Center Ludwigshafen
Study officials:
affiliation: Senior
name: Dimitra Kotsougiani-Fischer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: chief of department
name: Ulrich Kneser, MD
role: STUDY_CHAIR
affiliation: Senior
name: Julian Vogelpohl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nitkowski D, Petermann F. [Non-suicidal self-injury and comorbid mental disorders: a review]. Fortschr Neurol Psychiatr. 2011 Jan;79(1):9-20. doi: 10.1055/s-0029-1245772. Epub 2010 Nov 22. German.
citation: Monstrey S, Middelkoop E, Vranckx JJ, Bassetto F, Ziegler UE, Meaume S, Teot L. Updated scar management practical guidelines: non-invasive and invasive measures. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1017-25. doi: 10.1016/j.bjps.2014.04.011. Epub 2014 May 14.
citation: Chou CY, Chang HA, Chiao HY, Wang CY, Sun YS, Chen SG, Wang CH. Interchangeable skin grafting to camouflage self-inflicted wound scars on the dorsal and volar forearm: a case report. Ostomy Wound Manage. 2014 Apr;60(4):50-2.
citation: Bachtelle SE, Pepper CM. The Physical Results of Nonsuicidal Self-Injury: The Meaning Behind the Scars. J Nerv Ment Dis. 2015 Dec;203(12):927-933. doi: 10.1097/NMD.0000000000000398.