<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/NCT02224404</url>
  </required_header>
  <id_info>
    <org_study_id>CHEXU02</org_study_id>
    <nct_id>NCT02224404</nct_id>
  </id_info>
  <brief_title>Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended</brief_title>
  <official_title>Open, Non-comparative, Multi-centre Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended</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>
      The primary objective of this post market clinical follow-up (PMCF) investigation is to&#xD;
      evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure&#xD;
      ulcers (PU).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)</measure>
    <time_frame>6 weeks</time_frame>
    <description>the subjects will be measured by the following variables; maceration,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Pressure Ulcers</condition>
  <arm_group>
    <arm_group_label>Fast Gelling Dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fast Gelling Dressing (Exufiber)</intervention_name>
    <arm_group_label>Fast Gelling Dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both gender ≥18 years old.&#xD;
&#xD;
          2. Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)&#xD;
&#xD;
          3. Exuding pressure ulcer&#xD;
&#xD;
          4. Signed Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy/hypersensitivity to the dressing.&#xD;
&#xD;
          2. Infected wounds, (2 signs of infection/local inflammation and a positive swab)&#xD;
&#xD;
          3. Stage 1 PU&#xD;
&#xD;
          4. Dry wounds&#xD;
&#xD;
          5. Subjects who will have problems following the protocol&#xD;
&#xD;
          6. Subjects included in other ongoing clinical investigation at present or during the&#xD;
             past 30 days&#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>Hilde Beele, prof. dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Gent, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dep. of Plastic Surgery UZ Bruzzel</name>
      <address>
        <city>Brussel</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Gent, Belgium</name>
      <address>
        <city>Gent</city>
        <zip>9000 Gent</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatologie Campus Kennedylaan</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Töölö Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00260</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Finland</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>May 18, 2016</results_first_submitted>
  <results_first_submitted_qc>August 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 19, 2016</results_first_posted>
  <last_update_submitted>February 23, 2017</last_update_submitted>
  <last_update_submitted_qc>February 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</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>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fast Gelling Dressing</title>
          <description>Fast Gelling Dressing (Exufiber)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fast Gelling Dressing</title>
          <description>Fast Gelling Dressing (Exufiber)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </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="69.7" spread="19.9"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)</title>
        <description>the subjects will be measured by the following variables; maceration,</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fast Gelling Dressing</title>
            <description>Fast Gelling Dressing (Exufiber)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)</title>
          <description>the subjects will be measured by the following variables; maceration,</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance</title>
        <description>Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fast Gelling Dressing</title>
            <description>Fast Gelling Dressing (Exufiber)</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance</title>
          <description>Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Fast Gelling Dressing</title>
          <description>Fast Gelling Dressing (Exufiber)</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="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </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="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Periwound redness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hilde Beele</name_or_title>
      <organization>Universitair Ziekenhuis Gent</organization>
      <phone>09/332 22 87</phone>
      <email>Hilde.Beele@uzgent.be</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/NCT02224404
org study id: CHEXU02
nct id: NCT02224404
lead sponsor: 
has dmc: No
The primary objective of this post market clinical follow-up (PMCF) investigation is to
      evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure
      ulcers (PU).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
time frame: 6 weeks
description: the subjects will be measured by the following variables; maceration,
measure: Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
time frame: 6 weeks
description: Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm
arm group label: Fast Gelling Dressing
arm group type: Experimental
intervention type: Device
intervention name: Fast Gelling Dressing (Exufiber)
arm group label: Fast Gelling Dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hilde Beele, prof. dr
role: Principal Investigator
affiliation: University Hospital Gent, Belgium
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Finland
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 