<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/NCT03249909</url>
  </required_header>
  <id_info>
    <org_study_id>Exufiber Ag+ 01</org_study_id>
    <nct_id>NCT03249909</nct_id>
  </id_info>
  <brief_title>Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings</brief_title>
  <official_title>A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding&#xD;
      wounds&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">August 19, 2019</completion_date>
  <primary_completion_date type="Actual">August 19, 2019</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects were to be assigned in the following order:&#xD;
Eligible Subjects 1 to 50 were to be assigned to the Exufiber Ag+ cohort&#xD;
Eligible Subjects 51 to 65 were to be assigned to Exufiber&#xD;
Eligible Subjects 66 to 85 were to be assigned to Aquacel Ag Extra&#xD;
Eligible Subjects 86 to 105 were to be assigned to Exufiber Ag+ on eligible pressure ulcer subjects&#xD;
The statistical analysis of the groups treated will be analysed separately with the same statistical methods.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Exudate Status From Baseline to Last Visit</measure>
    <time_frame>4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
    <description>The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05.&#xD;
If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>4-Week Wound Status</measure>
    <time_frame>At 4 weeks (28 days)</time_frame>
    <description>The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days).&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Area Reduction (mm^2)</measure>
    <time_frame>Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
    <description>Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Dressing Changes Between Visits</measure>
    <time_frame>Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
    <description>Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment.&#xD;
Values over 1 indicate dressing changes were required between study follow up visits, for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Type of Wound Bed</measure>
    <time_frame>Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
    <description>Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour</measure>
    <time_frame>Total treatment period of 4 weeks (28 days)</time_frame>
    <description>Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation</measure>
    <time_frame>Total treatment period of 4 weeks (28 days)</time_frame>
    <description>Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration</measure>
    <time_frame>Total treatment period of 4 weeks (28 days)</time_frame>
    <description>Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handling and Technical Performance of the Dressing</measure>
    <time_frame>At 4 weeks (28 days)</time_frame>
    <description>Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days).&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort, Conformability, and Acceptability of the Dressings by Subject</measure>
    <time_frame>At 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
    <description>Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>Exufiber Ag +</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exufiber</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aquacel® Ag Extra</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exufiber Ag+</intervention_name>
    <description>gelling fibre dressing with silver</description>
    <arm_group_label>Aquacel® Ag Extra</arm_group_label>
    <arm_group_label>Exufiber</arm_group_label>
    <arm_group_label>Exufiber Ag +</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exufiber</intervention_name>
    <description>gelling fibre without silver</description>
    <arm_group_label>Aquacel® Ag Extra</arm_group_label>
    <arm_group_label>Exufiber</arm_group_label>
    <arm_group_label>Exufiber Ag +</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aquacel Ag Extra</intervention_name>
    <description>gelling fibre with silver</description>
    <arm_group_label>Aquacel® Ag Extra</arm_group_label>
    <arm_group_label>Exufiber</arm_group_label>
    <arm_group_label>Exufiber Ag +</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent Form&#xD;
&#xD;
          -  Both gender ≥ 18 years old&#xD;
&#xD;
          -  From Medium to High exuding wound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy or hypersensitivity to any of the treatment dressings&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Subjects with a target wound that is ≤1 cm2&#xD;
&#xD;
          -  Subjects with a target wound that is a full thickness burn&#xD;
&#xD;
          -  Subjects with a target wound that is a full thickness pressure ulcer&#xD;
&#xD;
          -  Subjects with known immunodeficiency&#xD;
&#xD;
          -  Subject taking systemic antibiotics for wound infection&#xD;
&#xD;
          -  Subject were the target wound is located on an infected limb interfered by minimal&#xD;
             blood flow in the opinion of the investigator&#xD;
&#xD;
          -  Subject with a target wound with unexplored enteric fistula&#xD;
&#xD;
          -  Subjects who in the opinion of the investigator, will have problems following the&#xD;
             protocol&#xD;
&#xD;
          -  Subjects needing treatment with oxidizing agents such as hypochlorite solutions or&#xD;
             hydrogen peroxide&#xD;
&#xD;
          -  Previously enrolled in the present investigation&#xD;
&#xD;
          -  Inclusion in other ongoing investigations at present that would preclude the subject&#xD;
             from participating in this investigation as judged by the investigator&#xD;
&#xD;
          -  Involvement in the planning and conduct of the clinical investigation&#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>Hadar Lev-Tov, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Midwestern University</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research, Inc.</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boise VA Medical Center (Boise VAMC) M</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jobst Vascular Institue (JVI)</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Serena Group Research Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>August 18, 2020</results_first_submitted>
  <results_first_submitted_qc>September 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 29, 2020</results_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</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>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03249909/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03249909/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Total enrolment was 109 subjects from 9 sites in the US, and was completed between 11 AUG 2017 and 12 JUN 2019.</recruitment_details>
      <pre_assignment_details>All enrolled subjects were assigned to a treatment group and treated in compliance with the Instructions For Use. No subject was excluded from the intent-to-treat (ITT) and safety population during analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Exufiber Ag+</title>
          <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="P2">
          <title>Exufiber</title>
          <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="P3">
          <title>Aquacel Ag Extra</title>
          <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Exufiber Ag+</title>
          <description>Exufiber Ag+ included treatment for 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="B2">
          <title>Exufiber</title>
          <description>Exufiber included treatment for 'chronic wounds' and 'acute wounds' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="B3">
          <title>Aquacel Ag Extra</title>
          <description>Aquacel Ag Extra included treatment for 'chronic wounds' and 'acute wounds' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="B4">
          <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="78"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="109"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" spread="13.9"/>
                    <measurement group_id="B2" value="56.9" spread="16.8"/>
                    <measurement group_id="B3" value="56.6" spread="11.5"/>
                    <measurement group_id="B4" value="61.6" spread="14.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.9" spread="8.8"/>
                    <measurement group_id="B2" value="35.8" spread="11.2"/>
                    <measurement group_id="B3" value="35.8" spread="10.9"/>
                    <measurement group_id="B4" value="33.7" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Exudate Status From Baseline to Last Visit</title>
        <description>The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05.&#xD;
If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.</description>
        <time_frame>4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
        <population>Intent To Treat (ITT) population with evaluable data to analyze change from baseline to last visit (n=75 for Exufiber Ag+; n=14 for Exufiber; n=16 for Aquacel Ag Extra)</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag +</title>
            <description>Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.&#xD;
Exufiber Ag+: gelling fibre dressing with silver&#xD;
Exufiber: gelling fibre without silver&#xD;
Aquacel Ag Extra: gelling fibre with silver</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.&#xD;
Exufiber Ag+: gelling fibre dressing with silver&#xD;
Exufiber: gelling fibre without silver&#xD;
Aquacel Ag Extra: gelling fibre with silver</description>
          </group>
          <group group_id="O3">
            <title>Aquacel® Ag Extra</title>
            <description>Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.&#xD;
Exufiber Ag+: gelling fibre dressing with silver&#xD;
Exufiber: gelling fibre without silver&#xD;
Aquacel Ag Extra: gelling fibre with silver</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Exudate Status From Baseline to Last Visit</title>
          <description>The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05.&#xD;
If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.</description>
          <population>Intent To Treat (ITT) population with evaluable data to analyze change from baseline to last visit (n=75 for Exufiber Ag+; n=14 for Exufiber; n=16 for Aquacel Ag Extra)</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="75"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Decreased exudate status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unchanged exudate status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased exudate status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups with the two-sided Sign test on the Intent To Treat (ITT) population at 95% confidence interval.</non_inferiority_desc>
            <p_value>0.0019</p_value>
            <method>Sign test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>4-Week Wound Status</title>
        <description>The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days).&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
        <time_frame>At 4 weeks (28 days)</time_frame>
        <population>Intent to Treat population with available data at 4 weeks (28 days) (n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra)</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>4-Week Wound Status</title>
          <description>The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days).&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
          <population>Intent to Treat population with available data at 4 weeks (28 days) (n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra)</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="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Stagnated</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Aggravated</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sames as baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Healed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wound Area Reduction (mm^2)</title>
        <description>Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
        <time_frame>Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
        <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Area Reduction (mm^2)</title>
          <description>Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
          <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-388.4" spread="707.6"/>
                    <measurement group_id="O2" value="-296.3" spread="2567.7"/>
                    <measurement group_id="O3" value="-274.7" spread="546.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Dressing Changes Between Visits</title>
        <description>Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment.&#xD;
Values over 1 indicate dressing changes were required between study follow up visits, for any reason.</description>
        <time_frame>Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Dressing Changes Between Visits</title>
          <description>Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment.&#xD;
Values over 1 indicate dressing changes were required between study follow up visits, for any reason.</description>
          <population>Intent to Treat population</population>
          <units>dressing changes / 7 days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="1.77"/>
                    <measurement group_id="O2" value="0.511" spread="0.633"/>
                    <measurement group_id="O3" value="3.56" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tissue Type of Wound Bed</title>
        <description>Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
        <time_frame>Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
        <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Tissue Type of Wound Bed</title>
          <description>Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
          <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
          <units>change in percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in percent of necrotic tissue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="14.73"/>
                    <measurement group_id="O2" value="1.54" spread="23.04"/>
                    <measurement group_id="O3" value="2.5" spread="8.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in percent of sloughy tissue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.48" spread="28.20"/>
                    <measurement group_id="O2" value="-2.69" spread="40.08"/>
                    <measurement group_id="O3" value="-0.833" spread="6.686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in percent of granulation tissue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.33" spread="37.14"/>
                    <measurement group_id="O2" value="-12.7" spread="40.1"/>
                    <measurement group_id="O3" value="-18.3" spread="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in percent of epithelialisation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="29.2"/>
                    <measurement group_id="O2" value="13.8" spread="29.6"/>
                    <measurement group_id="O3" value="16.7" spread="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour</title>
        <description>Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
        <time_frame>Total treatment period of 4 weeks (28 days)</time_frame>
        <population>Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour</title>
          <description>Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
          <population>Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</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="61"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Equal/Unchanged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation</title>
        <description>Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
        <time_frame>Total treatment period of 4 weeks (28 days)</time_frame>
        <population>Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation</title>
          <description>Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
          <population>Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</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="61"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Equal/Unchanged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration</title>
        <description>Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
        <time_frame>Total treatment period of 4 weeks (28 days)</time_frame>
        <population>Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration</title>
          <description>Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.&#xD;
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</description>
          <population>Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.</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="61"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Equal/Unchanged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Handling and Technical Performance of the Dressing</title>
        <description>Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days).&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</description>
        <time_frame>At 4 weeks (28 days)</time_frame>
        <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Handling and Technical Performance of the Dressing</title>
          <description>Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days).&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</description>
          <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</population>
          <units>% of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ease of application of dressing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.8"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of removal of dressing without moistening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.4"/>
                    <measurement group_id="O2" value="85.7"/>
                    <measurement group_id="O3" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Removal in one piece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to absorb exudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.4"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to absorb blood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to retain exudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to retain slough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to clean wound bed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ability to retain balanced moist environment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conformability to wound</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.3"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall experience</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.7"/>
                    <measurement group_id="O2" value="92.9"/>
                    <measurement group_id="O3" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comfort, Conformability, and Acceptability of the Dressings by Subject</title>
        <description>Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</description>
        <time_frame>At 4 weeks (28 days) or earlier if the wound is dry or healed</time_frame>
        <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</population>
        <group_list>
          <group group_id="O1">
            <title>Exufiber Ag+</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O2">
            <title>Exufiber</title>
            <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
          <group group_id="O3">
            <title>Aquacel Ag Extra</title>
            <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort, Conformability, and Acceptability of the Dressings by Subject</title>
          <description>Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed.&#xD;
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</description>
          <population>Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.</population>
          <units>% of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Comfort while wearing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.3"/>
                    <measurement group_id="O2" value="57.1"/>
                    <measurement group_id="O3" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of mobility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0"/>
                    <measurement group_id="O2" value="64.3"/>
                    <measurement group_id="O3" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Primary dressing remained in place</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2"/>
                    <measurement group_id="O2" value="64.3"/>
                    <measurement group_id="O3" value="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No stinging or burning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5"/>
                    <measurement group_id="O2" value="85.7"/>
                    <measurement group_id="O3" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall experience</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6"/>
                    <measurement group_id="O2" value="64.3"/>
                    <measurement group_id="O3" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse event data were collected for a period of 2 years, throughout enrollment and follow-up of this study</time_frame>
      <desc>There were no reports of death in any group throughout the study, and no reports of SAEs in the Exufiber group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Exufiber Ag+</title>
          <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="E2">
          <title>Exufiber</title>
          <description>Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
        <group group_id="E3">
          <title>Aquacel Ag Extra</title>
          <description>Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <description>In-patient hospitalization for cellulitis of the lower limb</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <description>In-patient hospitalization for right arm fistula</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Inability to eat</sub_title>
                <description>In-patient hospitalization for inability to eat</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Revisional transmetatarsal amputation right foot</sub_title>
                <description>In-patient hospitalization for transmetatarsal amputation on right foot with full thickness wound along surgical site.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <description>In-patient hospitalization following syncopal episode</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney injury</sub_title>
                <description>In-patient hospitalization for kidney injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>In-patient hospitalization for pneumonia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <description>In-patient hospitalization for shortness of breath</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infection on non-study foot</sub_title>
                <description>In-patient hospitalization for infection on non-study foot</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Exacerbation of congestive heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Peripheral artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <description>Cold, or flu-like symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pain in study wound</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pain not related to study wound</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis of non-study wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Cellulitis of study wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Infection of the study wound</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itching of the non-study wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Maceration in study wound</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>New ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </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>
    <limitations_and_caveats>This clinical investigation was limited in that it was non-comparative and based on a limited number of subjects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Andrea Marie Picchietti</name_or_title>
      <organization>Mölnlycke Health Care</organization>
      <phone>260 2583879</phone>
      <email>andrea.picchietti@molnlycke.com</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/NCT03249909
org study id: Exufiber Ag+ 01
nct id: NCT03249909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding
      wounds
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Subjects were to be assigned in the following order:
Eligible Subjects 1 to 50 were to be assigned to the Exufiber Ag+ cohort
Eligible Subjects 51 to 65 were to be assigned to Exufiber
Eligible Subjects 66 to 85 were to be assigned to Aquacel Ag Extra
Eligible Subjects 86 to 105 were to be assigned to Exufiber Ag+ on eligible pressure ulcer subjects
The statistical analysis of the groups treated will be analysed separately with the same statistical methods.
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Change in Exudate Status From Baseline to Last Visit
time frame: 4 weeks (28 days) or earlier if the wound is dry or healed
description: The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05.
If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.
measure: 4-Week Wound Status
time frame: At 4 weeks (28 days)
description: The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days).
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
measure: Wound Area Reduction (mm^2)
time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
description: Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement.
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
measure: Frequency of Dressing Changes Between Visits
time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
description: Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment.
Values over 1 indicate dressing changes were required between study follow up visits, for any reason.
measure: Tissue Type of Wound Bed
time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
description: Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages.
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
measure: Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour
time frame: Total treatment period of 4 weeks (28 days)
description: Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes.
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
measure: Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation
time frame: Total treatment period of 4 weeks (28 days)
description: Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
measure: Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration
time frame: Total treatment period of 4 weeks (28 days)
description: Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
measure: Handling and Technical Performance of the Dressing
time frame: At 4 weeks (28 days)
description: Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days).
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.
measure: Comfort, Conformability, and Acceptability of the Dressings by Subject
time frame: At 4 weeks (28 days) or earlier if the wound is dry or healed
description: Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed.
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.
arm group label: Exufiber Ag +
arm group type: Other
description: Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.
arm group label: Exufiber
arm group type: Other
description: Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.
arm group label: Aquacel® Ag Extra
arm group type: Other
description: Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis.
intervention type: Device
intervention name: Exufiber Ag+
description: gelling fibre dressing with silver
arm group label: Aquacel® Ag Extra
arm group label: Exufiber
arm group label: Exufiber Ag +
intervention type: Device
intervention name: Exufiber
description: gelling fibre without silver
arm group label: Aquacel® Ag Extra
arm group label: Exufiber
arm group label: Exufiber Ag +
intervention type: Device
intervention name: Aquacel Ag Extra
description: gelling fibre with silver
arm group label: Aquacel® Ag Extra
arm group label: Exufiber
arm group label: Exufiber Ag +
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hadar Lev-Tov, MD, MAS
role: Principal Investigator
affiliation: University of Miami
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Carboxymethylcellulose Sodium
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This clinical investigation was limited in that it was non-comparative and based on a limited number of subjects.
point of contact: 