<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/NCT01704950</url>
  </required_header>
  <id_info>
    <org_study_id>RECON-EMEA-11</org_study_id>
    <nct_id>NCT01704950</nct_id>
  </id_info>
  <brief_title>Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial</brief_title>
  <official_title>Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Services</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Integra LifeSciences Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to provide data and the guidelines for the use of IDRT SL in small&#xD;
      wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of&#xD;
      this product as a one stage procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Rate of graft take</measure>
    <time_frame>Day 15 after the surgery</time_frame>
    <description>the mean percentage of healing expected at Day 15 after the surgery</description>
  </primary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Traumatic Wound</condition>
  <condition>Reconstruction Wound</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Global population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological&#xD;
             wounds included)&#xD;
&#xD;
          -  Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted&#xD;
             (even if the patient is not taking part in the study) with a Split Thickness Skin&#xD;
             Graft in the same operating procedure&#xD;
&#xD;
          -  Wound treated with only one layer of a maximum size 10cm*12.5cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunosuppressed patient&#xD;
&#xD;
          -  Chronic wound (with no healing since 6 months)&#xD;
&#xD;
          -  Addition of any substances (growth factor, stem cells,…) in the IDRT SL during the&#xD;
             surgery&#xD;
&#xD;
          -  Patient with a corticoid treatment with a daily dose greater than 5 mg&#xD;
&#xD;
          -  Patients whose life expectancy is less than 12 months&#xD;
&#xD;
          -  Patients whose mental health or health condition (Visual deficiency, Alzheimers…)&#xD;
             would compromise completion of the self-evaluation questionnaires&#xD;
&#xD;
          -  Patient with an hypersensitivity to bovine collagen, chondroitin&#xD;
&#xD;
          -  Patient with clinical signs of infection (fever, pain, colour, swelling,…) and for&#xD;
             whom the investigator diagnosed infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefanos Papadopoulos</last_name>
    <role>Principal Investigator</role>
    <affiliation>General State Hospital of Athens, &quot;G. Gennimatas&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Josef Hospital</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General State Hospital of Athens, &quot;G. Gennimatas&quot; - Department of Plastic Surgery-Microsurgery and Burn Center</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital &quot;S. Maria della Misericordia&quot; - Plastic Surgery and Burn Center</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital - Burn and Plastic Surgery</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>February 24, 2016</last_update_submitted>
  <last_update_submitted_qc>February 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01704950
org study id: RECON-EMEA-11
nct id: NCT01704950
lead sponsor: 
has dmc: No
The aim of this study is to provide data and the guidelines for the use of IDRT SL in small
      wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of
      this product as a one stage procedure.
observational model: Cohort
time perspective: Prospective
measure: Rate of graft take
time frame: Day 15 after the surgery
description: the mean percentage of healing expected at Day 15 after the surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefanos Papadopoulos
role: Principal Investigator
affiliation: General State Hospital of Athens, "G. Gennimatas"
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Greece
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Wounds and Injuries