Cicatrix Clinical Trial
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
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.
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.
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