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

NCT04420442 | Unknown FDA Device

• 1 other identifier: BULudwigshafen
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonsuicidal Self Injury; Stigmatization; Cicatrix; Skin Transplantations

Outcome Measures

Primary Outcomes (11)

• body perception - Multidimensional Body Self Relations AS Questionnaire

  This questionnaire consists of 34 items that consists of 5 subscales. The items are rated on a 5 point likert scale. High scores indicate an increased dissatisfaction with body appearance and low scores indicate satisfaction with the body appearance. MBSRQ-AS subscale scores are the means of the constituent items after reversing contra-indicative items (i.e., 1 = 5, 2 = 4, 4 = 2, 5 = 1).

  36 months

• scar perception - Patient and Observer Scar Assessment Scale

  The questionnaire consists of two scales (patient and observer scale) and each scale consists of 6 items. The maximum value is 60 (worst outcome) and the minimum value is 6 (best outcome). (POSAS).

  36 months

• quality of life: SF-36 questionnaire

  This questionnaire consists of 36 items. The maximum value is 100 (best outcome) and the minimum value is 0 (worst outcome).

  36 months

• scar perception- Questionnaire for the evaluation of scar perception after burn trauma (FKBB)

  The questionnaire consists of 23 items and three introduction questions. The maximum score of each item is 5 (good body perception) and the lowest score is 1 (bad body perception). The overall score is calculated through the mean of the whole scale. The three introduction questions have a score of 0 (bad body perception) and 10 (good body perception). The questions are not part of the overall result, they are needed for the overall body acceptance and thereby for calculating the correlation between body perception and acceptance.

  36 months

• stigmatization - Self Disgust Scale

  The questionnaire is an 18-item scale. The items are rated on a 7-point likert scale. The maximum score was 84 and the minimum score was 12. A high score indicated high self-disgust and a low score indicated low self-disgust.

  36 months

• stigmatization - Self Regret Scale

  The questionnaire is a 21-item scale. The items are rated on a 5-point likert scale. The maximum score was 105 and the minimum score was 21. A high score indicated high levels of regret and a low score indicated a low regret level.

  36 months

• stigmatization - Self-Stigma of Mental Illness Scale (SSMIS-SF)

  This Scale consists of 4 subscales, each consisting of 5 items. On each subscale the maximum score is 45. There is no total score for the 4 subscales. The maximum score of each subscale is 45 and the minimum scale is 5. Higher scores are associated with higher levels of stigmatization.

  36 months

• stigmatization - Stigma Stress Scale

  This scale consists of two subscales. Each subscale consists of 4 items. The maximum score of each subscale is 28 and the minimum score is 4. The first subscale analyses the perceived stigma-related harm and the second subscale analyses the perceived coping resources. For analyzing the level of stigma stress the difference between the two subscales is calculated (harm minus coping - from -6 to +6). Higher scores are associated with higher levels of stigma stress.

  36 months

• stigmatization - Disclosure of psychological illness in public and private surroundings - scale

  Two items per subject. Highest score is 7 and the lowest score is 1. A low score indicates low levels of confidence with the patients psychological illness, whereby high scores indicate high levels of confidence with the psychological illness.

  36 months

• stigmatization - Internalized stigma of mental illness inventor (ISMII )

  This questionnaire consists of 5 items. The mean value is between 1 and 4. A high value is associated with a higher level of discrimination.

  36 months

• stigmatization - Self-labeling and Shame Scale

  Two items per subject. Highest score is 9 and associated with a high level of self-labelling and shame. Lowest score is is one and associated with a low level of self-labelling and shame.

  36 months

Secondary Outcomes (2)

• scar image

  36 months

• satisfaction with the aesthetic appearance: non-validated subjective questionnaire

  36 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Procedure: Scar Transformation Group

Control Group

NO INTERVENTION

No Intervention.

Interventions

Scar Transformation Group 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.

Also known as: Integra

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Berufsgenossenschaftliche Unfallklinik Ludwigshafen: lead
• Central Institute of Mental Health, Mannheim: collaborator

Study Sites (1)

BG Trauma Center Ludwigshafen

Ludwigshafen, 67071, Germany

RECRUITING

Related Publications (6)

• Turner BJ, Austin SB, Chapman AL. Treating nonsuicidal self-injury: a systematic review of psychological and pharmacological interventions. Can J Psychiatry. 2014 Nov;59(11):576-85. doi: 10.1177/070674371405901103.

  PMID: 25565473 RESULT

• 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.

  PMID: 24422986 RESULT

• 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.

  PMID: 21104583 RESULT

• 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.

  PMID: 24888226 RESULT

• 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.

  PMID: 24706403 RESULT

• 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.

  PMID: 26524516 RESULT

MeSH Terms

Conditions

Self-Injurious Behavior; Stereotyping; Cicatrix

Interventions

integra artificial skin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dimitra Kotsougiani-Fischer, MD

  Senior

  PRINCIPAL INVESTIGATOR

• Ulrich Kneser, MD

  chief of department

  STUDY CHAIR

• Julian Vogelpohl, MD

  Senior

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lucca Meynköhn, MD

CONTACT

+4962168108923; annalucca.meynkoehn@bgu-ludwigshafen.de

Dimitra Kotsougiani-Fischer, MD

CONTACT

+4962168108924; dimitra.kotsougiani@bgu-ludwigshafen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Privat Dozent Doctor med.

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: June 9, 2020
• Study Start: November 6, 2018
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2024
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)