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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | November 2024 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
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Germany | BG Trauma Center Ludwigshafen | Ludwigshafen |
Lead Sponsor | Collaborator |
---|---|
Berufsgenossenschaftliche Unfallklinik Ludwigshafen | Central Institute of Mental Health, Mannheim |
Germany,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | scar image | An objective analysis of the image of the scar and its constitution will be performed with the use of a 3D camera and cutometer measurements. With the cutometer the skin elasticity can objectively be assessed. | 36 months | |
Secondary | satisfaction with the aesthetic appearance: non-validated subjective questionnaire | A non-validated subjective questionnaire, especially designed for the study with focus on the aesthetic satisfaction with the scar, will be used. The questionnaire will use likert scales (score 0-4) with the best-achievable score of 4 points reflecting the highest satisfaction with the reconstructive result. | 36 months |
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