Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04420442
Study type Interventional
Source Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Contact Anna Lucca Meynköhn, MD
Phone +4962168108923
Email annalucca.meynkoehn@bgu-ludwigshafen.de
Status Recruiting
Phase N/A
Start date November 6, 2018
Completion date November 2024

See also
  Status Clinical Trial Phase
Completed NCT02645773 - Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring N/A
Completed NCT02672956 - Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results N/A
Completed NCT00629811 - Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women Phase 2
Completed NCT00847795 - Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects. Phase 1/Phase 2
Completed NCT00977951 - Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects Phase 1/Phase 2
Not yet recruiting NCT03213548 - Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty N/A
Recruiting NCT05377723 - Abdominal Scar Improvement in Microsurgical Breast Reconstruction N/A
Active, not recruiting NCT01976260 - A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars N/A
Terminated NCT00432328 - Juvista (Avotermin) in Breast Reduction Surgery Scars Phase 2
Completed NCT00984503 - Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites Phase 2
Completed NCT00594581 - Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males Phase 2
Completed NCT02772289 - Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars Phase 2
Completed NCT00430326 - Juvista (Avotermin) in Scars Following Varicose Vein Removal Phase 2
Completed NCT00847925 - Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects Phase 1/Phase 2
Recruiting NCT05787171 - Three Sutures With Different Absorption Rates for Lower Abdominal Incision N/A
Completed NCT02985151 - Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy N/A
Completed NCT02340325 - FS2 Safety and Tolerability Study in Healthy Volunteers Phase 1
Active, not recruiting NCT00432211 - Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery. Phase 2
Completed NCT00978302 - Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista) Phase 1
Withdrawn NCT04034615 - The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars Phase 2