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

NCT ID: NCT04420442

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2024-11-30

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.

Conditions

Nonsuicidal Self Injury; Stigmatization; Cicatrix; Skin Transplantations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

In addition to the comparison between arm 1 and 2, there will be an intraindividual comparison within arm 1.

Group Type: ACTIVE_COMPARATOR

Scar Transformation Group

Intervention Type: PROCEDURE

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.

Control Group

No Intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Integra

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: collaborator

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dimitra Kotsougiani-Fischer

Privat Dozent Doctor med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitra Kotsougiani-Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

Senior

Ulrich Kneser, MD

Role: STUDY_CHAIR

chief of department

Julian Vogelpohl, MD

Role: PRINCIPAL_INVESTIGATOR

Senior

Locations

BG Trauma Center Ludwigshafen

Ludwigshafen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Anna Lucca Meynköhn, MD

Role: CONTACT

annalucca.meynkoehn@bgu-ludwigshafen.de

+4962168108923

Dimitra Kotsougiani-Fischer, MD

Role: CONTACT

dimitra.kotsougiani@bgu-ludwigshafen.de

+4962168108924

Facility Contacts

Anna Lucca Meynköhn, MD

Role: primary

annalucca.meynkoehn@bgu-ludwigshafen.de

+49621 6810 8923

Dimitra Kotsougiani-Fischer, MD

Role: backup

dimitra.kotsougiani@bgu-ludwigshafen.de

+49621 6810 8924

References

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Reference Type: RESULT

PMID: 25565473 (View on PubMed)

Swannell SV, Martin GE, Page A, Hasking P, St John NJ. Prevalence of nonsuicidal self-injury in nonclinical samples: systematic review, meta-analysis and meta-regression. Suicide Life Threat Behav. 2014 Jun;44(3):273-303. doi: 10.1111/sltb.12070. Epub 2014 Jan 15.

Reference Type: RESULT

PMID: 24422986 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21104583 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24888226 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24706403 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26524516 (View on PubMed)

Other Identifiers

BULudwigshafen

Identifier Type: -

Identifier Source: org_study_id