<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/NCT03274466</url>
  </required_header>
  <id_info>
    <org_study_id>KCI.PREVENA.2017.01</org_study_id>
    <nct_id>NCT03274466</nct_id>
  </id_info>
  <brief_title>Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty</brief_title>
  <acronym>PROMISES</acronym>
  <official_title>Post-market, Randomized, Open-Label, Multicenter, Study to Evaluate the Effectiveness of Closed Incision Negative Pressure Therapy Versus Standard of Care Dressings in Reducing Surgical Site Complications in Subjects With Revision of a Failed Total Knee Arthroplasty (PROMISES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <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>
      This study evaluates surgical site complications in subjects undergoing revision of a total&#xD;
      knee arthroplasty when closed incision negative pressure therapy is used to manage the closed&#xD;
      incision, as compared to a standard of care dressing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">November 27, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Surgical Site Complications (SSC)</measure>
    <time_frame>within 90 days after TKA revision</time_frame>
    <description>The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following:&#xD;
Superficial Surgical Site Infection (SSI)&#xD;
Deep SSI&#xD;
Full thickness skin dehiscence&#xD;
Seroma or hematoma requiring drainage or surgery&#xD;
Skin necrosis&#xD;
Continued drainage at the time of dressing removal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)</measure>
    <time_frame>90 days after TKA revision</time_frame>
    <description>90 day subject incidence of any SSI (superficial or deep)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Deep Surgical Site Infection</measure>
    <time_frame>90 days after TKA revision</time_frame>
    <description>90 day subject incidence of deep surgical site infection</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Surgical Site Complication (SSC)</measure>
    <time_frame>within 90 days after TKA revision</time_frame>
    <description>The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following:&#xD;
Superficial Surgical Site Infection (SSI)&#xD;
Deep SSI&#xD;
Full thickness skin dehiscence&#xD;
Seroma or hematoma requiring drainage or surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">294</enrollment>
  <condition>Surgical Wound</condition>
  <condition>Revision Total Knee Arthroplasty</condition>
  <condition>Wounds and Injuries</condition>
  <condition>Joint Disease</condition>
  <condition>Musculoskeletal Disease</condition>
  <condition>Prosthesis-Related Infections</condition>
  <condition>Infection</condition>
  <condition>Postoperative Complications</condition>
  <condition>Pathologic Processes</condition>
  <arm_group>
    <arm_group_label>Closed Incision Negative Pressure Therapy (ciNPT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Silver impregnated dressing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Closed Incision Negative Pressure Therapy (ciNPT)</intervention_name>
    <description>Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
    <arm_group_label>Closed Incision Negative Pressure Therapy (ciNPT)</arm_group_label>
    <other_name>Prevena Peel &amp; Place</other_name>
    <other_name>Prevena Plus Customizable</other_name>
    <other_name>ActiV.A.C. Therapy Unit</other_name>
    <other_name>Prevena Plus 125 Therapy Unit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard of Care Dressing</intervention_name>
    <description>A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
    <arm_group_label>Standard of Care Dressing</arm_group_label>
    <other_name>Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Pre-operative Inclusion Criteria:&#xD;
&#xD;
        The subject:&#xD;
&#xD;
          -  is at least 22 years of age on the date of informed consent&#xD;
&#xD;
          -  is able to provide their own informed consent&#xD;
&#xD;
          -  requires a TKA revision defined as one of the following:&#xD;
&#xD;
               1. a one-stage aseptic revision procedure&#xD;
&#xD;
               2. a one-stage septic exchange procedure (requiring removal of all hardware) for&#xD;
                  acute postoperative infection&#xD;
&#xD;
               3. removal of cement spacer and re-implantation procedure&#xD;
&#xD;
               4. open reduction and internal fixation of peri-prosthetic fractures&#xD;
&#xD;
          -  has one or more of the following:&#xD;
&#xD;
               1. a body mass index (BMI) greater than 35 kg/m2&#xD;
&#xD;
               2. a requirement for the use of blood thinners other than acetylsalicylic acid (ASA)&#xD;
                  after surgery&#xD;
&#xD;
               3. history of or current peripheral vascular disease&#xD;
&#xD;
               4. the presence of lymphedema in the operative limb&#xD;
&#xD;
               5. insulin-dependent diabetes mellitus&#xD;
&#xD;
               6. current tobacco use or previous history of smoking and quitting within the past&#xD;
                  30 days&#xD;
&#xD;
               7. a history of prior infection of the operative site&#xD;
&#xD;
               8. current use of immunomodulators or steroids&#xD;
&#xD;
               9. current or history of cancer or hematological malignancy (excluding localized&#xD;
                  skin cancer)&#xD;
&#xD;
              10. rheumatoid arthritis&#xD;
&#xD;
              11. current renal failure or dialysis&#xD;
&#xD;
              12. malnutrition as determined by the investigator&#xD;
&#xD;
              13. liver disease as determined by the investigator&#xD;
&#xD;
              14. status post solid organ transplant&#xD;
&#xD;
              15. HIV&#xD;
&#xD;
          -  is willing and able to return for all scheduled study visits&#xD;
&#xD;
          -  if female, has a negative urine or serum pregnancy test at screening and day of&#xD;
             revision surgery. Women who have had surgical sterilization by a medically accepted&#xD;
             method such as tubal ligation, hysterectomy, or oophorectomy or are post-menopausal,&#xD;
             defined as not having menstruation for &gt;= 12 months will be excluded from requiring&#xD;
             this test.&#xD;
&#xD;
        Intra-operative Inclusion Criteria:&#xD;
&#xD;
        The subject:&#xD;
&#xD;
          -  continues to meet all pre-operative inclusion criteria&#xD;
&#xD;
          -  has undergone a TKA revision resulting in a closed surgical incision&#xD;
&#xD;
        Pre-operative Exclusion Criteria:&#xD;
&#xD;
        The subject:&#xD;
&#xD;
          -  is pregnant or lactating&#xD;
&#xD;
          -  will undergo a bilateral TKA within the same operative visit&#xD;
&#xD;
          -  will undergo a bilateral TKA in which the first TKA surgery is on the knee selected&#xD;
             for study&#xD;
&#xD;
          -  will undergo a staged bilateral TKA in which the TKA revision surgery for the knee&#xD;
             under study occurs within 30 days of the first TKA procedure&#xD;
&#xD;
          -  was previously randomized in this protocol&#xD;
&#xD;
          -  has a systemic active infection at the time of revision not including chronic viral&#xD;
             infections such as HIV or hepatitis&#xD;
&#xD;
          -  has a remote-site skin infection at the time of revision&#xD;
&#xD;
          -  was tattooed on the area of the incision within 30 days prior to randomization&#xD;
&#xD;
          -  has known sensitivity to the study product components (drape and/or dressing materials&#xD;
             in direct contact with the closed incision or skin)&#xD;
&#xD;
          -  has known sensitivity to silver&#xD;
&#xD;
          -  is currently enrolled in another investigational trial that requires additional&#xD;
             interventions&#xD;
&#xD;
          -  is planned to be enrolled in another investigational trial that requires additional&#xD;
             interventions at any time during the study&#xD;
&#xD;
          -  has localized skin cancer around the incision site&#xD;
&#xD;
        Intra-operative Exclusion Criteria:&#xD;
&#xD;
        The subject:&#xD;
&#xD;
          -  is found to meet any of the pre-operative exclusion criteria&#xD;
&#xD;
          -  has a surgical incision that precludes placement of dressing&#xD;
&#xD;
          -  has a TKA revision resulting in a muscle flap&#xD;
&#xD;
          -  has a TKA revision resulting in the placement of a spacer&#xD;
&#xD;
          -  has an incision drainage and debridement procedure only&#xD;
&#xD;
          -  has a surgical incision closed with skin glue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Higuera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Orthopedics &amp; Spine Hospital</name>
      <address>
        <city>Tucker</city>
        <state>Georgia</state>
        <zip>30084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Science Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health Care</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health - SouthSide Hospital</name>
      <address>
        <city>Bay Shore</city>
        <state>New York</state>
        <zip>11706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University (NYU)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health - Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joint Implant Surgeons</name>
      <address>
        <city>New Albany</city>
        <state>Ohio</state>
        <zip>43054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rothman Institute - Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>32743</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>November 11, 2020</results_first_submitted>
  <results_first_submitted_qc>January 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2021</results_first_posted>
  <last_update_submitted>July 29, 2022</last_update_submitted>
  <last_update_submitted_qc>July 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Prosthesis-Related Infections</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Pathologic Processes</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03274466/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03274466/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
          <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care Dressing</title>
          <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Specified Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </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="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized Subjects (ITT)</population>
      <group_list>
        <group group_id="B1">
          <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
          <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care Dressing</title>
          <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="147"/>
            <count group_id="B2" value="147"/>
            <count group_id="B3" value="294"/>
          </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="147"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.7" spread="9.48"/>
                    <measurement group_id="B2" value="65.1" spread="8.51"/>
                    <measurement group_id="B3" value="64.9" spread="9.00"/>
                  </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="147"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</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="147"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="259"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</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="147"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="147"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>centimeters</description>
          <population>Data missing from 1 subject.</population>
          <units>centimeters</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="147"/>
                    <count group_id="B2" value="146"/>
                    <count group_id="B3" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.8" spread="10.39"/>
                    <measurement group_id="B2" value="168.3" spread="10.58"/>
                    <measurement group_id="B3" value="169.1" spread="10.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <description>kilograms</description>
          <units>kilograms</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="147"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100.4" spread="21.79"/>
                    <measurement group_id="B2" value="96.6" spread="22.08"/>
                    <measurement group_id="B3" value="98.5" spread="21.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <population>Data missing for 1 subject.</population>
          <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="147"/>
                    <count group_id="B2" value="146"/>
                    <count group_id="B3" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.7" spread="6.73"/>
                    <measurement group_id="B2" value="34.2" spread="7.18"/>
                    <measurement group_id="B3" value="34.5" spread="6.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Surgical Site Complications (SSC)</title>
        <description>The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following:&#xD;
Superficial Surgical Site Infection (SSI)&#xD;
Deep SSI&#xD;
Full thickness skin dehiscence&#xD;
Seroma or hematoma requiring drainage or surgery&#xD;
Skin necrosis&#xD;
Continued drainage at the time of dressing removal</description>
        <time_frame>within 90 days after TKA revision</time_frame>
        <population>Modified Intent-To-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
            <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Dressing</title>
            <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Surgical Site Complications (SSC)</title>
          <description>The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following:&#xD;
Superficial Surgical Site Infection (SSI)&#xD;
Deep SSI&#xD;
Full thickness skin dehiscence&#xD;
Seroma or hematoma requiring drainage or surgery&#xD;
Skin necrosis&#xD;
Continued drainage at the time of dressing removal</description>
          <population>Modified Intent-To-Treat</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="125"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Modified Intent-To-Treat</non_inferiority_desc>
            <p_value>0.0013</p_value>
            <p_value_desc>Threshold for statistical significance: alpha = 0.048</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>0.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)</title>
        <description>90 day subject incidence of any SSI (superficial or deep)</description>
        <time_frame>90 days after TKA revision</time_frame>
        <population>Modified Intent-To-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
            <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Dressing</title>
            <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)</title>
          <description>90 day subject incidence of any SSI (superficial or deep)</description>
          <population>Modified Intent-To-Treat</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="125"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Modified Intent-To-Treat</non_inferiority_desc>
            <p_value>0.1680</p_value>
            <p_value_desc>Threshold for Statistical Significance: alpha = 0.048</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>1.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Deep Surgical Site Infection</title>
        <description>90 day subject incidence of deep surgical site infection</description>
        <time_frame>90 days after TKA revision</time_frame>
        <population>Modified Intent-To-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
            <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Dressing</title>
            <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Deep Surgical Site Infection</title>
          <description>90 day subject incidence of deep surgical site infection</description>
          <population>Modified Intent-To-Treat</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="125"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Modified Intent-To-Treat</non_inferiority_desc>
            <p_value>0.3386</p_value>
            <p_value_desc>Threshold for Statistical Significance: alpha = 0.048</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>3.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Surgical Site Complication (SSC)</title>
        <description>The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following:&#xD;
Superficial Surgical Site Infection (SSI)&#xD;
Deep SSI&#xD;
Full thickness skin dehiscence&#xD;
Seroma or hematoma requiring drainage or surgery</description>
        <time_frame>within 90 days after TKA revision</time_frame>
        <population>Intent-To-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
            <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Dressing</title>
            <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Surgical Site Complication (SSC)</title>
          <description>The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following:&#xD;
Superficial Surgical Site Infection (SSI)&#xD;
Deep SSI&#xD;
Full thickness skin dehiscence&#xD;
Seroma or hematoma requiring drainage or surgery</description>
          <population>Intent-To-Treat</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="147"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0013</p_value>
            <p_value_desc>Threshold for statistical significance: alpha = 0.048</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>0.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>104 days</time_frame>
      <desc>The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Closed Incision Negative Pressure Therapy (ciNPT)</title>
          <description>Prevena Peel &amp; Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit&#xD;
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care Dressing</title>
          <description>Silver impregnated dressing&#xD;
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <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="1" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Hypertensive Heart Disease</sub_title>
                <description>Hypertensive Coronary Disease Death</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Fibrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Stitch abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Stress fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Unresponsive to stimuli</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status change</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arthrotomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Joint manipulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Wound drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="140"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <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="24" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="140"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wound Drainage</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="140"/>
              </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>Director of Clinical Research</name_or_title>
      <organization>KCI | 3M</organization>
      <phone>(210) 515-4060</phone>
      <email>actate@mmm.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/NCT03274466
org study id: KCI.PREVENA.2017.01
nct id: NCT03274466
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study evaluates surgical site complications in subjects undergoing revision of a total
      knee arthroplasty when closed incision negative pressure therapy is used to manage the closed
      incision, as compared to a standard of care dressing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Surgical Site Complications (SSC)
time frame: within 90 days after TKA revision
description: The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following:
Superficial Surgical Site Infection (SSI)
Deep SSI
Full thickness skin dehiscence
Seroma or hematoma requiring drainage or surgery
Skin necrosis
Continued drainage at the time of dressing removal
measure: Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
time frame: 90 days after TKA revision
description: 90 day subject incidence of any SSI (superficial or deep)
measure: Number of Participants With Deep Surgical Site Infection
time frame: 90 days after TKA revision
description: 90 day subject incidence of deep surgical site infection
measure: Number of Participants With Surgical Site Complication (SSC)
time frame: within 90 days after TKA revision
description: The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following:
Superficial Surgical Site Infection (SSI)
Deep SSI
Full thickness skin dehiscence
Seroma or hematoma requiring drainage or surgery
arm group label: Closed Incision Negative Pressure Therapy (ciNPT)
arm group type: Experimental
description: Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit
arm group label: Standard of Care Dressing
arm group type: Active Comparator
description: Silver impregnated dressing
intervention type: Device
intervention name: Closed Incision Negative Pressure Therapy (ciNPT)
description: Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
arm group label: Closed Incision Negative Pressure Therapy (ciNPT)
other name: Prevena Peel & Place
other name: Prevena Plus Customizable
other name: ActiV.A.C. Therapy Unit
other name: Prevena Plus 125 Therapy Unit
intervention type: Device
intervention name: Standard of Care Dressing
description: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
arm group label: Standard of Care Dressing
other name: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Higuera, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Prosthesis-Related Infections
mesh term: Joint Diseases
mesh term: Musculoskeletal Diseases
mesh term: Postoperative Complications
mesh term: Pathologic Processes
mesh term: Wounds and Injuries
mesh term: Surgical Wound
mesh term: Carboxymethylcellulose Sodium
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 