Nonsuicidal Self InjuryNCT04420442
Scar Resection and Reconstruction With Integra and Split Skin Grafts in Patients With Non-Suicidal Self-Inflicted Scars
A study testing Scar Transformation Group in people with Nonsuicidal Self Injury and Stigmatization, run by Berufsgenossenschaftliche Unfallklinik Ludwigshafen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nonsuicidal Self Injury, Stigmatization, Cicatrix
- What is being tested?
- Scar Transformation Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 6 Nov 2018to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
BG Trauma Center Ludwigshafen
Ludwigshafen, 67071
Anna Lucca Meynköhn, MD, +49621 6810 8923, annalucca.meynkoehn@bgu-ludwigshafen.de
Dimitra Kotsougiani-Fischer, MD, +49621 6810 8924, dimitra.kotsougiani@bgu-ludwigshafen.de
About this study
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.
Read the 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.
- Being tested
- Scar Transformation Group
- Medical subject headings
- Self-Injurious Behavior, Stereotyping, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar Transformation GroupProcedure or surgery
Also called Integra
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | In addition to the comparison between arm 1 and 2, there will be an intraindividual comparison within arm 1. Receives: Procedure: Scar Transformation Group |
| Control Group | No intervention | No Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months
Secondary outcomes (2)
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.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start6 Nov 2018
- Primary completionNov 2022 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nonsuicidal Self InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berufsgenossenschaftliche Unfallklinik Ludwigshafen
- Sponsor type
- University, hospital or other
- Collaborators
- Central Institute of Mental Health, Mannheim
- Responsible party
- Principal investigator, Dr. Dimitra Kotsougiani-Fischer, Berufsgenossenschaftliche Unfallklinik Ludwigshafen
- Investigators
- Dimitra Kotsougiani-Fischer, MD, Principal investigator, SeniorUlrich Kneser, MD, Study chair, chief of departmentJulian Vogelpohl, MD, Principal investigator, Senior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420442
- Sponsor's protocol ID
- BULudwigshafen
- Status last verified
- Jun 2020
- First submitted
- 26 Feb 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25565473Swannell 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.
PubMed 24422986Nitkowski 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.
PubMed 21104583Monstrey 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.
PubMed 24888226Chou 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.
PubMed 24706403Bachtelle 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.
PubMed 26524516
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04420442
- Acronym / sponsor ID
- BULudwigshafen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Berufsgenossenschaftliche Unfallklinik LudwigshafenUniversity, hospital or other
- Collaborators
- Central Institute of Mental Health, Mannheim
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Procedure: Scar Transformation GroupIn addition to the comparison between arm 1 and 2, there will be an intraindividual comparison within arm 1. |
| Control Group | No intervention | –No Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scar Transformation GroupAlso: IntegraSurgical 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. | Procedure or surgery | Intervention Group |
Primary outcome
body perception - Multidimensional Body Self Relations AS Questionnaire
Time frame: 36 months
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).
scar perception - Patient and Observer Scar Assessment Scale
Time frame: 36 months
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).
quality of life: SF-36 questionnaire
Time frame: 36 months
This questionnaire consists of 36 items. The maximum value is 100 (best outcome) and the minimum value is 0 (worst outcome).
scar perception- Questionnaire for the evaluation of scar perception after burn trauma (FKBB)
Time frame: 36 months
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.
stigmatization - Self Disgust Scale
Time frame: 36 months
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.
stigmatization - Self Regret Scale
Time frame: 36 months
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.
stigmatization - Self-Stigma of Mental Illness Scale (SSMIS-SF)
Time frame: 36 months
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.
stigmatization - Stigma Stress Scale
Time frame: 36 months
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.
stigmatization - Disclosure of psychological illness in public and private surroundings - scale
Time frame: 36 months
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.
stigmatization - Internalized stigma of mental illness inventor (ISMII )
Time frame: 36 months
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.
stigmatization - Self-labeling and Shame Scale
Time frame: 36 months
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.
2 secondary outcomes
scar image
Time frame: 36 months
satisfaction with the aesthetic appearance: non-validated subjective questionnaire
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Results publication: PubMed 25565473Turner 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.
- Results publication: PubMed 24422986Swannell 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.
- Results publication: PubMed 21104583Nitkowski 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.
- Results publication: PubMed 24888226Monstrey 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.
- Results publication: PubMed 24706403Chou 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.
- Results publication: PubMed 26524516Bachtelle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitra Kotsougiani-Fischer, MD principal investigator
Senior
Ulrich Kneser, MD study chair
chief of department
Julian Vogelpohl, MD principal investigator
Senior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scar Transformation Group in people with Nonsuicidal Self Injury and Stigmatization, run by Berufsgenossenschaftliche Unfallklinik Ludwigshafen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Lucca Meynköhn, MD (+4962168108923, annalucca.meynkoehn@bgu-ludwigshafen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body perception - Multidimensional Body Self Relations AS Questionnaire (time frame: 36 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420442, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.