<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/NCT02237118</url>
  </required_header>
  <id_info>
    <org_study_id>MPTO 05</org_study_id>
    <nct_id>NCT02237118</nct_id>
  </id_info>
  <brief_title>Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)&quot;</brief_title>
  <acronym>Only</acronym>
  <official_title>Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Molnlycke Health Care AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Molnlycke Health Care AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)</measure>
    <time_frame>21 days</time_frame>
    <description>To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.</measure>
    <time_frame>21 days</time_frame>
    <description>Complete healing at day 21, will be measured using PictZar system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Condition of the Wound, Will be Assesst by the Investigator.</measure>
    <time_frame>21 days</time_frame>
    <description>wound size estimation, assesstemnt of the wound,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>21 days</time_frame>
    <description>Adverse Event, Adverse Device Event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the Surrounding Skin.</measure>
    <time_frame>21 days</time_frame>
    <description>assessment of the surrounding skin.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Mepitel One</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pain on dressing removal, by VAS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UrgoTul</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pain on removal by VAS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mepitel One</intervention_name>
    <arm_group_label>Mepitel One</arm_group_label>
    <arm_group_label>UrgoTul</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UrgoTul</intervention_name>
    <arm_group_label>Mepitel One</arm_group_label>
    <arm_group_label>UrgoTul</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring&#xD;
             the use of dressings&#xD;
&#xD;
          2. Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2&#xD;
             investigational products maximum)&#xD;
&#xD;
          3. Wound whose duration is ≤ 3 days&#xD;
&#xD;
          4. Both gender with an age ≥ 18 years&#xD;
&#xD;
          5. Subject able to understand and voluntarily sign the informed consent&#xD;
&#xD;
          6. Subject able to follow the protocol&#xD;
&#xD;
          7. Subject insured to the French social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Surgical wound&#xD;
&#xD;
          2. Infected, moderately to strongly exudative and haemorrhagic wound&#xD;
&#xD;
          3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by&#xD;
             the investigator, could interfere with the pain assessment&#xD;
&#xD;
          4. Known allergy/hypersensitivity to any of the components of the investigational&#xD;
             products&#xD;
&#xD;
          5. Participation in other clinical investigation within one month prior to start of&#xD;
             investigation&#xD;
&#xD;
          6. Pregnant or breast-feeding women&#xD;
&#xD;
          7. Person protected by a legal regime (tutorship or guardianship)&#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>Anna Solanilla, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Mutualiste du Medoc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Mutualiste du Medoc</name>
      <address>
        <city>Lespare</city>
        <zip>33340</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>May 3, 2016</results_first_submitted>
  <results_first_submitted_qc>February 24, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 10, 2017</results_first_posted>
  <last_update_submitted>February 24, 2017</last_update_submitted>
  <last_update_submitted_qc>February 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute</keyword>
  <keyword>wound</keyword>
  <keyword>management</keyword>
  <keyword>measured</keyword>
  <keyword>Visual analoge scale</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mepitel One</title>
          <description>Pain on dressing removal, by VAS&#xD;
Mepitel One</description>
        </group>
        <group group_id="P2">
          <title>UrgoTul</title>
          <description>Pain on removal by VAS&#xD;
UrgoTul</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>consent withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mepitel One</title>
          <description>Pain on dressing removal, by VAS&#xD;
Mepitel One&#xD;
UrgoTul</description>
        </group>
        <group group_id="B2">
          <title>UrgoTul</title>
          <description>Pain on dressing removal, by VAS&#xD;
Mepitel One&#xD;
UrgoTul</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.8" spread="21.2"/>
                    <measurement group_id="B2" value="59.8" spread="23.0"/>
                    <measurement group_id="B3" value="62.3" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)</title>
        <description>To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.</description>
        <time_frame>21 days</time_frame>
        <population>intention to treat.Participants with None painfull dressing removal.</population>
        <group_list>
          <group group_id="O1">
            <title>Mepitel One</title>
            <description>Non-Painful dressing removal, measured by VAS&#xD;
Mepitel One&#xD;
UrgoTul</description>
          </group>
          <group group_id="O2">
            <title>UrgoTul</title>
            <description>Non-Painful dressing removal, measured by VAS&#xD;
Mepitel One&#xD;
UrgoTul</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)</title>
          <description>To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.</description>
          <population>intention to treat.Participants with None painfull dressing removal.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.</title>
        <description>Complete healing at day 21, will be measured using PictZar system.</description>
        <time_frame>21 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mepitel One</title>
            <description>Complete healing was reported for 39 subjects ( 68,4%) in the Mepitel One group.</description>
          </group>
          <group group_id="O2">
            <title>UrgoTul</title>
            <description>Complete healing was reported for 27 subjects ( 49,1%) in theUrgoTul group.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.</title>
          <description>Complete healing at day 21, will be measured using PictZar system.</description>
          <units>percentage of wound size reduction</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="1.97"/>
                    <measurement group_id="O2" value="0.52" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Condition of the Wound, Will be Assesst by the Investigator.</title>
        <description>wound size estimation, assesstemnt of the wound,</description>
        <time_frame>21 days</time_frame>
        <population>Missing value for some patients</population>
        <group_list>
          <group group_id="O1">
            <title>Condition of the Wound Mepitel One</title>
            <description>Condition of the wound assesed by the investigator</description>
          </group>
          <group group_id="O2">
            <title>Condition of the Wound, UrgoTul</title>
            <description>Condition of the wound, UrgoTul, assessed by the investigator</description>
          </group>
        </group_list>
        <measure>
          <title>Condition of the Wound, Will be Assesst by the Investigator.</title>
          <description>wound size estimation, assesstemnt of the wound,</description>
          <population>Missing value for some patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granulation tissue in growth in the dressing holes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety</title>
        <description>Adverse Event, Adverse Device Event</description>
        <time_frame>21 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safety Mepitel One</title>
            <description>Adverse Event and Adverse Device Effect</description>
          </group>
          <group group_id="O2">
            <title>Safety UrgoTul</title>
            <description>Adverse Event and Adverse Device Effect</description>
          </group>
        </group_list>
        <measure>
          <title>Safety</title>
          <description>Adverse Event, Adverse Device Event</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Subject with Adverse Event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subject with Adverse Device Effect</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subject with non AE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of the Surrounding Skin.</title>
        <description>assessment of the surrounding skin.</description>
        <time_frame>21 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mepitel One</title>
            <description>Condition of the surrounding skin</description>
          </group>
          <group group_id="O2">
            <title>UrgoTul</title>
            <description>Condition of the surrounding skin</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of the Surrounding Skin.</title>
          <description>assessment of the surrounding skin.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Inflammatory signs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allergic rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blistering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin stripping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trauma to wound edges</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Product degradation on the skin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Mepitel One</title>
          <description>Pain on dressing removal, by VAS&#xD;
Mepitel One&#xD;
UrgoTul</description>
        </group>
        <group group_id="E2">
          <title>UrgoTul</title>
          <description>Pain on removal by VAS&#xD;
Mepitel One&#xD;
UrgoTul</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>pulmonary rhythm disorder</sub_title>
                <description>pulmonary rhythm disorder, leading to hospitalisation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>cardiac insufficiency</sub_title>
                <description>cardiac insufficiency, both leading to hospitalisation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Necrosis of left heel, diabetes</sub_title>
                <description>Necrosis of left heel, diabetes, leading to hospitalisation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastro intestinal bleeding</sub_title>
                <description>gastro intestinal bleeding, life threatening</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for cardiac insufficiency</sub_title>
                <description>Hospitalization for cardiac insufficiency</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>cardiorespiratory failure</sub_title>
                <description>cardiorespiratory failure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GASTROINTESTINAL BLEEDING</sub_title>
                <description>GASTROINTESTINAL BLEEDING</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fall</sub_title>
                <description>fall</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ANKLE SPRAIN</sub_title>
                <description>ANKLE SPRAIN</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>RIGHT BASAL PULMONARY</sub_title>
                <description>RIGHT BASAL PULMONARY</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>acute bronchitis</sub_title>
                <description>acute bronchitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>cutaneous eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>ALLERGY</sub_title>
                <description>ALLERGY</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>acute elbow cellulite</sub_title>
                <description>acute elbow cellulite</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>another wound surinfection with stapylococcus epidermidis</sub_title>
                <description>another wond surinfection with stapylococcus epidermidis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>ERYSIPELE</sub_title>
                <description>ERYSIPELE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>NECROSE necrosis on the left heel</sub_title>
                <description>NECROSE necrosis on the left heel</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Anne Solanilla</name_or_title>
      <organization>Clinique Mutualiste du Medoc</organization>
      <phone>+33 5 56 73 11 43</phone>
      <email>annasolanilla@yahoo.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02237118
org study id: MPTO 05
nct id: NCT02237118
lead sponsor: 
has dmc: No
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound
      management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
time frame: 21 days
description: To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.
measure: Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.
time frame: 21 days
description: Complete healing at day 21, will be measured using PictZar system.
measure: Condition of the Wound, Will be Assesst by the Investigator.
time frame: 21 days
description: wound size estimation, assesstemnt of the wound,
measure: Safety
time frame: 21 days
description: Adverse Event, Adverse Device Event
measure: Assessment of the Surrounding Skin.
time frame: 21 days
description: assessment of the surrounding skin.
arm group label: Mepitel One
arm group type: Active Comparator
description: Pain on dressing removal, by VAS
arm group label: UrgoTul
arm group type: Active Comparator
description: Pain on removal by VAS
intervention type: Device
intervention name: Mepitel One
arm group label: Mepitel One
arm group label: UrgoTul
intervention type: Device
intervention name: UrgoTul
arm group label: Mepitel One
arm group label: UrgoTul
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Solanilla, Dr
role: Principal Investigator
affiliation: Clinique Mutualiste du Medoc
facility: 
country: France
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 