<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04420442</url>
  </required_header>
  <id_info>
    <org_study_id>BULudwigshafen</org_study_id>
    <nct_id>NCT04420442</nct_id>
  </id_info>
  <brief_title>Scar Resection and Reconstruction With Integra and Split Skin Grafts in Patients With Non-Suicidal Self-Inflicted Scars</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Berufsgenossenschaftliche Unfallklinik Ludwigshafen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Institute of Mental Health, Mannheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Berufsgenossenschaftliche Unfallklinik Ludwigshafen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-suicidal self-inflicted (NSSI) scars can act as a physical reminder of previous&#xD;
      self-inflicted self-harm, thereby not only worsening the symptoms of depression and&#xD;
      self-doubt but also leading to recurrent self-infliction and social exclusion. Several&#xD;
      different treatment options exist to alter the appearance of NSSI scars like pulsed-dye laser&#xD;
      therapy (PDL), non-ablative fractional laser therapy, dermabrasion or elliptical excision.&#xD;
      However, none of these treatment options can completely diminish the scars. In the majority&#xD;
      of cases, the unique scar pattern of NSSI scars and in addition to that the &quot;reminder&quot;&#xD;
      remains. In contrast to regular scar revisions, the aesthetical appearance is not the most&#xD;
      important outcome parameter as the main focus of the surgical treatment is destigmatization.&#xD;
      The surgical transformation of the scar into a burn-like scar could change the&#xD;
      scar-perception of the society and the patient, thereby improving the patient's quality of&#xD;
      life and body perception. Surgical resection with preservation of the subcutaneous tissue&#xD;
      followed by consecutive reconstruction with a bilayer dermal regenerative matrix (IntegraTM)&#xD;
      and split skin grafts might represent a promising and novel therapeutic approach. The&#xD;
      hypothesis is that by surgically transforming the non-suicidal self-inflicted scars into a&#xD;
      burn-like scar the patient's body and scar perception will be positively altered and the&#xD;
      stigmatization by the society reduced.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-suicidal self-injury behaviour describes behaviour in patients, who have no intention to&#xD;
      commit suicide. This can be performed in many different ways, e.g., automutilation through&#xD;
      burning, scratching, or hitting. Often this behaviour results in deep scars and&#xD;
      disfigurements. The prevalence of patients with NSSI scars is estimated to be 13.4% in&#xD;
      adolescents and 5.5% in adults. Non-suicidal behaviour is often associated with other&#xD;
      psychological diseases like personality disorders, character disorders of the Borderline&#xD;
      type, anxiety, and substance abuse disorders. In these cases, usually, interdisciplinary&#xD;
      therapy concepts are needed. A major problem is that the scars due to its constant&#xD;
      confrontation can induce repetitive non-suicidal self-injury behaviour. Furthermore, the&#xD;
      image of the NSSI scars leads to stigmatization by society and in addition to that to a&#xD;
      withdrawal from society by the patients. Hence, the need for adequate treatment of the NSSI&#xD;
      scars to relief the burden of stigmatization for the patients is immense. At the moment,&#xD;
      non-invasive therapies like pulsed-dye laser therapy (PDL) and non-ablative fractional laser&#xD;
      therapy, as well as minimal-invasive therapies like dermabrasion or elliptical excision offer&#xD;
      one possible option, but the undoubted cause of the scar remains visible. At the moment only&#xD;
      case studies exist which describe the beneficial effect of surgical resection followed by&#xD;
      consecutive reconstruction with a dermal regenerative matrix and split skin grafts. These&#xD;
      studies have evaluated the aesthetic outcome and briefly assessed the well-being of the&#xD;
      patients. However, currently, no study exists investigating the effect of the two-step&#xD;
      surgical procedure on body perception and the psychological outcome in general. The overall&#xD;
      goal of the described study is to establish a therapy concept for patients who suffer from&#xD;
      constant confrontation with their NSSI scars. Stigmatization by the society and by the&#xD;
      patients themselves, body perception, quality of life, and scar perception will be evaluated&#xD;
      over the study period of 36 months. Furthermore, the scar itself will be assessed using a&#xD;
      cutometer and the scar image will be evaluated using the Patient and Observer Scar Assessment&#xD;
      Scale.&#xD;
&#xD;
      The data analyses will be performed with SPSS, version 20.0, SPSS Inc. Chicago, USA. For the&#xD;
      normally distributed values, the paired T-test will be used. Not normally distributed values&#xD;
      will be analysed by the Wilcoxon signed-rank Test. The significance level will be set at&#xD;
      p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body perception - Multidimensional Body Self Relations AS Questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>scar perception - Patient and Observer Scar Assessment Scale</measure>
    <time_frame>36 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of life: SF-36 questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>This questionnaire consists of 36 items. The maximum value is 100 (best outcome) and the minimum value is 0 (worst outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>scar perception- Questionnaire for the evaluation of scar perception after burn trauma (FKBB)</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Self Disgust Scale</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Self Regret Scale</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Self-Stigma of Mental Illness Scale (SSMIS-SF)</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Stigma Stress Scale</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Disclosure of psychological illness in public and private surroundings - scale</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Internalized stigma of mental illness inventor (ISMII )</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stigmatization - Self-labeling and Shame Scale</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>scar image</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction with the aesthetic appearance: non-validated subjective questionnaire</measure>
    <time_frame>36 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Nonsuicidal Self Injury</condition>
  <condition>Stigmatization</condition>
  <condition>Cicatrix</condition>
  <condition>Skin Transplantations</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to the comparison between arm 1 and 2, there will be an intraindividual comparison within arm 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scar Transformation Group</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Integra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with non-suicidal self-inflicted scars (NSSI) on the forearms who have&#xD;
             resigned from self-infliction for more than one year can be included in the study.&#xD;
&#xD;
          -  The patients have to be older than 18 years old. Their psychological status has to be&#xD;
             stable and certified by a psychologist.&#xD;
&#xD;
          -  Patients have to have a high psychosocial pressure due to the non-suicidal&#xD;
             self-inflicted scars on the forearms.&#xD;
&#xD;
          -  Patients have to agree to supportive psychotherapy during the time of the study.&#xD;
&#xD;
          -  Patients have to agree to wear their compression gear for 12 months after the surgical&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancies&#xD;
&#xD;
          -  Age younger than 18&#xD;
&#xD;
          -  Any other comorbid conditions like body-dysmorphic conditions or eating disorders&#xD;
&#xD;
          -  Tendency to develop hypertrophic scars or keloids&#xD;
&#xD;
          -  The participation in other clinical studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitra Kotsougiani-Fischer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulrich Kneser, MD</last_name>
    <role>Study Chair</role>
    <affiliation>chief of department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julian Vogelpohl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Lucca Meynköhn, MD</last_name>
    <phone>+4962168108923</phone>
    <email>annalucca.meynkoehn@bgu-ludwigshafen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dimitra Kotsougiani-Fischer, MD</last_name>
    <phone>+4962168108924</phone>
    <email>dimitra.kotsougiani@bgu-ludwigshafen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BG Trauma Center Ludwigshafen</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67071</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Lucca Meynköhn, MD</last_name>
      <phone>+49621 6810 8923</phone>
      <email>annalucca.meynkoehn@bgu-ludwigshafen.de</email>
    </contact>
    <contact_backup>
      <last_name>Dimitra Kotsougiani-Fischer, MD</last_name>
      <phone>+49621 6810 8924</phone>
      <email>dimitra.kotsougiani@bgu-ludwigshafen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>25565473</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24422986</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>21104583</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24888226</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24706403</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>26524516</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Berufsgenossenschaftliche Unfallklinik Ludwigshafen</investigator_affiliation>
    <investigator_full_name>Dr. Dimitra Kotsougiani-Fischer</investigator_full_name>
    <investigator_title>Privat Dozent Doctor med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
    <mesh_term>Self-Injurious Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04420442
org study id: BULudwigshafen
nct id: NCT04420442
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
measure: body perception - Multidimensional Body Self Relations AS Questionnaire
time frame: 36 months
description: 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).
measure: scar perception - Patient and Observer Scar Assessment Scale
time frame: 36 months
description: 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).
measure: quality of life: SF-36 questionnaire
time frame: 36 months
description: This questionnaire consists of 36 items. The maximum value is 100 (best outcome) and the minimum value is 0 (worst outcome).
measure: scar perception- Questionnaire for the evaluation of scar perception after burn trauma (FKBB)
time frame: 36 months
description: 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.
measure: stigmatization - Self Disgust Scale
time frame: 36 months
description: 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.
measure: stigmatization - Self Regret Scale
time frame: 36 months
description: 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.
measure: stigmatization - Self-Stigma of Mental Illness Scale (SSMIS-SF)
time frame: 36 months
description: 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.
measure: stigmatization - Stigma Stress Scale
time frame: 36 months
description: 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.
measure: stigmatization - Disclosure of psychological illness in public and private surroundings - scale
time frame: 36 months
description: 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.
measure: stigmatization - Internalized stigma of mental illness inventor (ISMII )
time frame: 36 months
description: 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.
measure: stigmatization - Self-labeling and Shame Scale
time frame: 36 months
description: 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.
measure: scar image
time frame: 36 months
description: 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.
measure: satisfaction with the aesthetic appearance: non-validated subjective questionnaire
time frame: 36 months
description: 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.
arm group label: Intervention Group
arm group type: Active Comparator
description: In addition to the comparison between arm 1 and 2, there will be an intraindividual comparison within arm 1.
arm group label: Control Group
arm group type: No Intervention
description: No Intervention.
intervention type: Procedure
intervention name: Scar Transformation Group
description: 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.
arm group label: Intervention Group
other name: Integra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dimitra Kotsougiani-Fischer, MD
role: Principal Investigator
affiliation: Senior
last name: Ulrich Kneser, MD
role: Study Chair
affiliation: chief of department
last name: Julian Vogelpohl, MD
role: Principal Investigator
affiliation: Senior
last name: Anna Lucca Meynköhn, MD
phone: +4962168108923
email: annalucca.meynkoehn@bgu-ludwigshafen.de
last name: Dimitra Kotsougiani-Fischer, MD
phone: +4962168108924
email: dimitra.kotsougiani@bgu-ludwigshafen.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
investigator full name: Dr. Dimitra Kotsougiani-Fischer
investigator title: Privat Dozent Doctor med.
mesh term: Cicatrix
mesh term: Self-Injurious Behavior
sharing ipd: No