<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/NCT03016078</url>
  </required_header>
  <id_info>
    <org_study_id>MxB Po Ag 01</org_study_id>
    <nct_id>NCT03016078</nct_id>
  </id_info>
  <brief_title>Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty</brief_title>
  <official_title>A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall rationale for this investigation is to evaluate the clinical performance&#xD;
      potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related&#xD;
      post-operative wound complications such as blistering, maceration and redness at the incision&#xD;
      and surrounding skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a descriptive, open, prospective, non-controlled clinical investigation conducted on&#xD;
      21 enrolled subjects at one site in the United states of America (USA).&#xD;
&#xD;
      The target subjects were male or female, 18 years and older, undergoing elective primary hip&#xD;
      or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after&#xD;
      surgery. The primary purpose was to investigate if there was any skin damage under the&#xD;
      dressing from operation day to last visit. Performance of the dressing as well as comfort,&#xD;
      conformability, acceptability and pain at dressing removal was also followed-up until post-op&#xD;
      day 7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">April 7, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Damage to the Incision and Surrounding Skin</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:&#xD;
Blistering (Yes/No) by visit&#xD;
Redness under dressing (Yes/No) by visit&#xD;
Redness outside dressing (Yes/No) by visit&#xD;
Maceration under dressing (Yes/No) by visit&#xD;
Maceration outside dressing (Yes/No) by visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Leakage of the Dressing</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>Nurse/ Investigator evaluate: Leakage (No/Yes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dressing Sticking to the Staples/Sutures</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bleeding Caused by Dressing Removal</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' Dressing Wear Time (Days)</measure>
    <time_frame>7 days</time_frame>
    <description>The number of days the dressing can stay on are evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Dressing Changes Per Subject</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>To evaluate the number of dressing changes per subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the Dressing Capacity of Handling Blood</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)</measure>
    <time_frame>Daily visits, up to 7 days</time_frame>
    <description>Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).&#xD;
Nurse/ Investigator evaluate with No/Yes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Arthroplasties, Hip Replacement</condition>
  <condition>Arthroplasties, Knee Replacement</condition>
  <arm_group>
    <arm_group_label>Mepilex Border Post-Op Ag Dressing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mepilex Border Post-Op Ag</intervention_name>
    <description>To investigate if there was any skin damage under the dressing from operation day to last visit.</description>
    <arm_group_label>Mepilex Border Post-Op Ag Dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Available for a follow-up visit including dressing change 7 days after surgery&#xD;
&#xD;
          3. Plan for elective primary hip or knee arthroplasty&#xD;
&#xD;
          4. Plan for incision size ≤18 cm&#xD;
&#xD;
          5. Provision of informed consent i.e. subject must be able to understand and sign the&#xD;
             Patient Information and Consent Form&#xD;
&#xD;
          6. Undergoing elective primary arthroplasty of the hip or knee.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Known allergy/hypersensitivity to any of the components of the dressing&#xD;
&#xD;
          2. Multi-trauma&#xD;
&#xD;
          3. Undergoing arthroplasty due to tumor&#xD;
&#xD;
          4. Previous incision at the same knee or same side of the hip&#xD;
&#xD;
          5. Wound at the surgical site prior to surgery&#xD;
&#xD;
          6. Neurological deficit of operated side (hemiplegia, etc.)&#xD;
&#xD;
          7. Documented skin disease at time of enrollment, as judged by the investigator&#xD;
&#xD;
          8. Previously enrolled in the present investigation&#xD;
&#xD;
          9. 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;
         10. Involvement in the planning and conduct of the clinical investigation (applies to all&#xD;
             MHC staff, investigational site staff and third party vendor)&#xD;
&#xD;
         11. Dressing size does not fit the incision area (&gt;18 cm)&#xD;
&#xD;
         12. Complications that would increase wound risks if investigational dressing is applied&#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>Steven Myerthall, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Orthopedic Research and Education, The CORE Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The CORE Institute Gilbert</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>January 16, 2018</results_first_submitted>
  <results_first_submitted_qc>February 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2018</results_first_posted>
  <last_update_submitted>February 13, 2018</last_update_submitted>
  <last_update_submitted_qc>February 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>November 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03016078/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Investigation period: Feb 2017 - March 2017. The study was conducted on 21 enrolled subjects at one site in the US. Subjects included were 18 years, and above, undergoing elective primary hip or knee arthroplasty.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Mepilex Border Post-Op Ag Dressing</title>
          <description>A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All variables measured at baseline were summarised for the ITT and PP populations using appropriate summary statistics.</population>
      <group_list>
        <group group_id="B1">
          <title>Mepilex Border Post-Op Ag Dressing</title>
          <description>A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.4" spread="5.8"/>
                  </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="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blistering</title>
          <units>Number of blisters</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Damage to the Incision and Surrounding Skin</title>
        <description>The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:&#xD;
Blistering (Yes/No) by visit&#xD;
Redness under dressing (Yes/No) by visit&#xD;
Redness outside dressing (Yes/No) by visit&#xD;
Maceration under dressing (Yes/No) by visit&#xD;
Maceration outside dressing (Yes/No) by visit</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Damage to the Incision and Surrounding Skin</title>
          <description>The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:&#xD;
Blistering (Yes/No) by visit&#xD;
Redness under dressing (Yes/No) by visit&#xD;
Redness outside dressing (Yes/No) by visit&#xD;
Maceration under dressing (Yes/No) by visit&#xD;
Maceration outside dressing (Yes/No) by visit</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blistering visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blistering visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blistering visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness Under Dressing visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness Under Dressing visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness Under Dressing visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness Outside Dressing visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness Outside Dressing visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness Outside Dressing visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration Under Dressing visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration Under Dressing visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration Under Dressing visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration Outside Dressing visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration Outside Dressing visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maceration Outside Dressing visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Leakage of the Dressing</title>
        <description>Nurse/ Investigator evaluate: Leakage (No/Yes)</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Leakage of the Dressing</title>
          <description>Nurse/ Investigator evaluate: Leakage (No/Yes)</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leakage visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leakage visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leakage visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leakage visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dressing Sticking to the Staples/Sutures</title>
        <description>Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dressing Sticking to the Staples/Sutures</title>
          <description>Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dressing sticks to the staples visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dressing sticks to the staples visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dressing sticks to the staples visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bleeding Caused by Dressing Removal</title>
        <description>Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bleeding Caused by Dressing Removal</title>
          <description>Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bleeding caused by the dressing removal visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding caused by the dressing removal visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding caused by the dressing removal visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Dressing Wear Time (Days)</title>
        <description>The number of days the dressing can stay on are evaluated</description>
        <time_frame>7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Dressing Wear Time (Days)</title>
          <description>The number of days the dressing can stay on are evaluated</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
          <units>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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.35" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Dressing Changes Per Subject</title>
        <description>To evaluate the number of dressing changes per subject</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Dressing Changes Per Subject</title>
          <description>To evaluate the number of dressing changes per subject</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
          <units>Number of dressing changes per subject</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of the Dressing Capacity of Handling Blood</title>
        <description>Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of the Dressing Capacity of Handling Blood</title>
          <description>Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Poor visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very good visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very good visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very good visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable visit 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)</title>
        <description>Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).&#xD;
Nurse/ Investigator evaluate with No/Yes</description>
        <time_frame>Daily visits, up to 7 days</time_frame>
        <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>The Study Group</title>
            <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)</title>
          <description>Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).&#xD;
Nurse/ Investigator evaluate with No/Yes</description>
          <population>The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Average of one Week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>The Study Group</title>
          <description>Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.</description>
        </group>
      </group_list>
      <serious_events>
        <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="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Redness at border of derssing</sub_title>
                <description>Study subject had a distinctive border of redness where the silicone border was present. Subject denied any itching or pain at the incision site, but the PI confirmed it was an AE with a possible relation ADE.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Research Director</name_or_title>
      <organization>Mölnlycke Health Care</organization>
      <phone>+46 31 722 30 00</phone>
      <email>info@monlycke.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/NCT03016078
org study id: MxB Po Ag 01
nct id: NCT03016078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The overall rationale for this investigation is to evaluate the clinical performance
      potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related
      post-operative wound complications such as blistering, maceration and redness at the incision
      and surrounding skin.
This was a descriptive, open, prospective, non-controlled clinical investigation conducted on
      21 enrolled subjects at one site in the United states of America (USA).

      The target subjects were male or female, 18 years and older, undergoing elective primary hip
      or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after
      surgery. The primary purpose was to investigate if there was any skin damage under the
      dressing from operation day to last visit. Performance of the dressing as well as comfort,
      conformability, acceptability and pain at dressing removal was also followed-up until post-op
      day 7.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Damage to the Incision and Surrounding Skin
time frame: Daily visits, up to 7 days
description: The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:
Blistering (Yes/No) by visit
Redness under dressing (Yes/No) by visit
Redness outside dressing (Yes/No) by visit
Maceration under dressing (Yes/No) by visit
Maceration outside dressing (Yes/No) by visit
measure: Number of Participants With Leakage of the Dressing
time frame: Daily visits, up to 7 days
description: Nurse/ Investigator evaluate: Leakage (No/Yes)
measure: Number of Participants With Dressing Sticking to the Staples/Sutures
time frame: Daily visits, up to 7 days
description: Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
measure: Number of Participants With Bleeding Caused by Dressing Removal
time frame: Daily visits, up to 7 days
description: Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
measure: Participants' Dressing Wear Time (Days)
time frame: 7 days
description: The number of days the dressing can stay on are evaluated
measure: Number of Dressing Changes Per Subject
time frame: Daily visits, up to 7 days
description: To evaluate the number of dressing changes per subject
measure: Evaluation of the Dressing Capacity of Handling Blood
time frame: Daily visits, up to 7 days
description: Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
measure: Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)
time frame: Daily visits, up to 7 days
description: Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).
Nurse/ Investigator evaluate with No/Yes
arm group label: Mepilex Border Post-Op Ag Dressing
arm group type: Other
description: A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
intervention type: Device
intervention name: Mepilex Border Post-Op Ag
description: To investigate if there was any skin damage under the dressing from operation day to last visit.
arm group label: Mepilex Border Post-Op Ag Dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Myerthall, Dr
role: Principal Investigator
affiliation: Center for Orthopedic Research and Education, The CORE Institute
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 