<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/NCT04490213</url>
  </required_header>
  <id_info>
    <org_study_id>2018/212-31</org_study_id>
    <nct_id>NCT04490213</nct_id>
  </id_info>
  <brief_title>Scarring At Donor Sites After Split-Thickness Skin Graft.</brief_title>
  <official_title>Scarring At Donor Sites After Split-Thickness Skin Graft: A Prospective, Longitudinal, Randomised Trial; The Observer's View</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate if previous findings on the association between&#xD;
      dressing treatments and subjective opinion on final donor site scar outcome using the patient&#xD;
      scale of POSAS could be confirmed objectively.&#xD;
&#xD;
      Scar outcome measurements were assessed by a blinded observer using POSAS and the device:&#xD;
      Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany) to measure the&#xD;
      viscoelasticity of the skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the third and last part of a clinical project concerning the treatment of split&#xD;
      thickness skin graft donor sites. In the first part the Investigators completed a randomised&#xD;
      clinical trial (RCT) in which donor sites were randomly assigned to treatment with either&#xD;
      hydrofibre covered with film, non-adhesive polyurethane foam, or porcine xenograft. Results&#xD;
      from the first study indicated that donor sites treated with hydrofibre and porcine xenograft&#xD;
      healed significantly faster than those treated with polyurethane foam. As the hydrofibre was&#xD;
      the most comfortable, easy to use, and cost-effective it was implemented as the standard of&#xD;
      care for donor sites at the specific centre.&#xD;
&#xD;
      In the initial RCT, patients treated with polyurethane foam showed significantly longer&#xD;
      healing times than the other treatment groups. As longer healing time has been shown to be a&#xD;
      predictor for pathological donor site scarring it was hypothesised that this group would be&#xD;
      the most unsatisfied with their scars, if they had any donor site scar at all eight years&#xD;
      after their skin graft. In the second part of the project the long-term scar outcomes of the&#xD;
      donor sites included in the RCT was investigated. Study participants were asked to evaluate&#xD;
      their scars using the &quot;Patients part&quot; of the Patient and Observer Scar Scale (POSAS). After&#xD;
      analysing the data collected in the second part, it was concluded that the fast and moist&#xD;
      healing seen with hydrofibre seemed to result in significantly more satisfied patients - and&#xD;
      members of the polyurethane foam group, as hypothesised, were significantly more unsatisfied&#xD;
      with their donor site scars. The Investigators also found that the dressing associated with&#xD;
      the fastest wound healing (the porcine xenograft) also had the poorest long-term outcome for&#xD;
      scarring, according to the patients' opinion. This contradicts what is claimed to be the&#xD;
      relation between duration of healing and donor site scarring.&#xD;
&#xD;
      In this last, third study, the aim was to investigate if the previous findings could be&#xD;
      confirmed by an evaluation done by a blinded observer using POSAS. Donor sites were also&#xD;
      evaluated for firmness and elasticity using the device; Cutometer dual MPA 580 (Courage and&#xD;
      Khazaka Electronic GmbH, Cologne, Germany), which is described in the Method section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>donor sites scar outcome according to a blinded observer</measure>
    <time_frame>within 9 years after surgery</time_frame>
    <description>evaluated with the scar scale Patient and Observer Scar Assesment Scale (POSAS). The scale contains six items that are scored numerically and when added, constitutes the &quot;Total Score&quot; of the Patient or the Observer Scale. Each of the six items on both scales has a 10-point range (1 - 10), with 10 indicating the worst imaginable scar or sensation. The lowest score, &quot;1&quot; corresponds to the normal skin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>donor sites scar outcome according to a cutometer</measure>
    <time_frame>within 9 years after surgery</time_frame>
    <description>measurement of elasticity and firmness with cutometer</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Donor Site Complication</condition>
  <arm_group>
    <arm_group_label>hydrofibre, Aquacel</arm_group_label>
    <description>Study participants were previously treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites</description>
  </arm_group>
  <arm_group>
    <arm_group_label>polyurethane foam, Allevyn</arm_group_label>
    <description>Study participants were previolsuy treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites</description>
  </arm_group>
  <arm_group>
    <arm_group_label>porcine xenograft, Mediskin</arm_group_label>
    <description>Study participants were previolsuy treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Allevyn, Aquacel and Tegaderm, Mediskin</intervention_name>
    <description>Wound dressing tested earlier on donor sites, in this study scar outcome between the 3 dressing groups are compared.</description>
    <arm_group_label>hydrofibre, Aquacel</arm_group_label>
    <arm_group_label>polyurethane foam, Allevyn</arm_group_label>
    <arm_group_label>porcine xenograft, Mediskin</arm_group_label>
    <other_name>polyurethan foam, hydrofibre, film, porcone xenograft</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Of the 27 participants in the second part of the study, two had died, six (with a total of&#xD;
        8 donor sites) chose not to participate and two did not answer our letter. The remaining 17&#xD;
        were included in the Observer follow up. Of the 17 participants, five came from the&#xD;
        hydrofibre group, six from the polyurethane foam, and six from porcine xenograft group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participation in part I (RCT) and part II of the project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No former participation in the project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Burn Centre at Linköping University Hospital,</name>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 26, 2019</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Folke Sjoberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboxymethylcellulose Sodium</mesh_term>
  </intervention_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/NCT04490213
org study id: 2018/212-31
nct id: NCT04490213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate if previous findings on the association between
      dressing treatments and subjective opinion on final donor site scar outcome using the patient
      scale of POSAS could be confirmed objectively.

      Scar outcome measurements were assessed by a blinded observer using POSAS and the device:
      Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany) to measure the
      viscoelasticity of the skin.
This is the third and last part of a clinical project concerning the treatment of split
      thickness skin graft donor sites. In the first part the Investigators completed a randomised
      clinical trial (RCT) in which donor sites were randomly assigned to treatment with either
      hydrofibre covered with film, non-adhesive polyurethane foam, or porcine xenograft. Results
      from the first study indicated that donor sites treated with hydrofibre and porcine xenograft
      healed significantly faster than those treated with polyurethane foam. As the hydrofibre was
      the most comfortable, easy to use, and cost-effective it was implemented as the standard of
      care for donor sites at the specific centre.

      In the initial RCT, patients treated with polyurethane foam showed significantly longer
      healing times than the other treatment groups. As longer healing time has been shown to be a
      predictor for pathological donor site scarring it was hypothesised that this group would be
      the most unsatisfied with their scars, if they had any donor site scar at all eight years
      after their skin graft. In the second part of the project the long-term scar outcomes of the
      donor sites included in the RCT was investigated. Study participants were asked to evaluate
      their scars using the "Patients part" of the Patient and Observer Scar Scale (POSAS). After
      analysing the data collected in the second part, it was concluded that the fast and moist
      healing seen with hydrofibre seemed to result in significantly more satisfied patients - and
      members of the polyurethane foam group, as hypothesised, were significantly more unsatisfied
      with their donor site scars. The Investigators also found that the dressing associated with
      the fastest wound healing (the porcine xenograft) also had the poorest long-term outcome for
      scarring, according to the patients' opinion. This contradicts what is claimed to be the
      relation between duration of healing and donor site scarring.

      In this last, third study, the aim was to investigate if the previous findings could be
      confirmed by an evaluation done by a blinded observer using POSAS. Donor sites were also
      evaluated for firmness and elasticity using the device; Cutometer dual MPA 580 (Courage and
      Khazaka Electronic GmbH, Cologne, Germany), which is described in the Method section.
observational model: Cohort
time perspective: Prospective
measure: donor sites scar outcome according to a blinded observer
time frame: within 9 years after surgery
description: evaluated with the scar scale Patient and Observer Scar Assesment Scale (POSAS). The scale contains six items that are scored numerically and when added, constitutes the "Total Score" of the Patient or the Observer Scale. Each of the six items on both scales has a 10-point range (1 - 10), with 10 indicating the worst imaginable scar or sensation. The lowest score, "1" corresponds to the normal skin.
measure: donor sites scar outcome according to a cutometer
time frame: within 9 years after surgery
description: measurement of elasticity and firmness with cutometer
arm group label: hydrofibre, Aquacel
description: Study participants were previously treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites
arm group label: polyurethane foam, Allevyn
description: Study participants were previolsuy treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites
arm group label: porcine xenograft, Mediskin
description: Study participants were previolsuy treated on their donor sites with these CE-marked dressing products (RCT study published in 2014) and are now compared regarding scar outcome at the donor sites
intervention type: Other
intervention name: Allevyn, Aquacel and Tegaderm, Mediskin
description: Wound dressing tested earlier on donor sites, in this study scar outcome between the 3 dressing groups are compared.
arm group label: hydrofibre, Aquacel
arm group label: polyurethane foam, Allevyn
arm group label: porcine xenograft, Mediskin
other name: polyurethan foam, hydrofibre, film, porcone xenograft
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Folke Sjoberg
investigator title: Professor
mesh term: Cicatrix
mesh term: Carboxymethylcellulose Sodium
sharing ipd: No