<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/NCT03009110</url>
  </required_header>
  <id_info>
    <org_study_id>IRB ID #: 201603062</org_study_id>
    <secondary_id>1R01HD086007-01A1</secondary_id>
    <nct_id>NCT03009110</nct_id>
  </id_info>
  <brief_title>Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial</brief_title>
  <acronym>Prevena-C</acronym>
  <official_title>Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large&#xD;
      pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness,&#xD;
      safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a&#xD;
      closed, sealed system that applies negative pressure to the wound surface via a single-use,&#xD;
      battery-powered, portable device - to decrease surgical site infections (SSIs) in obese&#xD;
      women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental evidence suggests that NPWT promotes wound healing by removing exudate,&#xD;
      approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index&#xD;
      [BMI] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese&#xD;
      women. The increased risk of SSIs is in part due to the increased thickness of the&#xD;
      subcutaneous space, allowing collection of exudates and increasing tension on wound edges,&#xD;
      promoting the growth of bacteria, and leading to wound infection and breakdown. Thus,&#xD;
      prophylactic NPWT may be particularly effective in this patient population.&#xD;
&#xD;
      During the 5-year project period, investigators from 4 collaborating perinatal centers in the&#xD;
      United Stated (two university and two community) will randomize 2850 obese women undergoing&#xD;
      cesarean delivery to receive either prophylactic negative pressure wound therapy with the&#xD;
      Prevena device or standard wound dressing. Women will be followed up to 30 days&#xD;
      postoperatively to ascertain study outcomes.&#xD;
&#xD;
      The primary outcome for the trial is superficial or deep SSI after cesarean according to the&#xD;
      CDC's National Healthcare Safety Network definitions. The investigators will also assess&#xD;
      other wound complications, adverse events potentially attributable to NPWT and&#xD;
      cost-effectiveness as measured by incremental cost per case of SSI prevented and per&#xD;
      quality-adjusted life year (QALY).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    DSMB recommendation following interim analysis&#xD;
  </why_stopped>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">November 13, 2019</completion_date>
  <primary_completion_date type="Actual">November 13, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>As defined according to the CDC's National Healthcare Safety Network criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>As defined according to the CDC's National Healthcare Safety Network criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Pain Score</measure>
    <time_frame>At discharge, an average of 4 days postoperatively</time_frame>
    <description>On a scale of 0 (least) - 10 (most).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Pain Score</measure>
    <time_frame>At postoperative day 30</time_frame>
    <description>On a scale of 0 (least) - 10 (most).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Score</measure>
    <time_frame>At discharge, an average of 4 days postoperatively</time_frame>
    <description>On a scale of 0 (least) - 10 (most).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Score</measure>
    <time_frame>At postoperative day 30</time_frame>
    <description>On a scale of 0 (least) - 10 (most).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incremental Cost Per SSI Prevented</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incremental Cost Per Quality-Adjusted Life-year</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk Factors for Surgical Site Infections in Obese Women</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1624</enrollment>
  <condition>Surgical Wound Infection</condition>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Prophylactic NPWT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prophylactic NPWT</intervention_name>
    <description>The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
    <arm_group_label>Prophylactic NPWT</arm_group_label>
    <other_name>Prevena</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Dressing</intervention_name>
    <description>Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
    <arm_group_label>Standard Dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Gestational age ≥23weeks&#xD;
&#xD;
          -  BMI≥30 Pre-pregnancy or BMI at first prenatal visit&#xD;
&#xD;
          -  Planned or unplanned cesarean delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-availability for postoperative follow-up&#xD;
&#xD;
          -  Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing&#xD;
             infection around incision site, Bleeding disorder, Therapeutic anticoagulation,&#xD;
             Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic,&#xD;
             silicone, adhesive tape)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Methodius G Tuuli, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eskenazi Hopsital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Baptist Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hosptial St Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.</citation>
    <PMID>24056202</PMID>
  </reference>
  <reference>
    <citation>Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 2015 May-Jun;60(5-6):211-8.</citation>
    <PMID>26126306</PMID>
  </reference>
  <reference>
    <citation>Bullough, L, Wilkinson, D., Burns, S, Wan, L, Changing wound care protocols to reduce postoperative caesarean section infection and readmission, Wounds , 2014 (10), 1 : 72 - 76. 46</citation>
  </reference>
  <reference>
    <citation>Chaboyer W, Anderson V, Webster J, Sneddon A, Thalib L, Gillespie BM. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel). 2014 Sep 30;2(4):417-28. doi: 10.3390/healthcare2040417.</citation>
    <PMID>27429285</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <results_first_submitted>February 5, 2021</results_first_submitted>
  <results_first_submitted_qc>May 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2023</results_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>David Haas</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03009110/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03009110/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prophylactic NPWT</title>
          <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
        </group>
        <group group_id="P2">
          <title>Standard Dressing</title>
          <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="816"/>
                <participants group_id="P2" count="808"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="806"/>
                <participants group_id="P2" count="802"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prophylactic NPWT</title>
          <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
        </group>
        <group group_id="B2">
          <title>Standard Dressing</title>
          <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</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="806"/>
            <count group_id="B2" value="802"/>
            <count group_id="B3" value="1608"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="805"/>
                    <measurement group_id="B2" value="797"/>
                    <measurement group_id="B3" value="1602"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.8" spread="5.6"/>
                    <measurement group_id="B2" value="30.1" spread="5.9"/>
                    <measurement group_id="B3" value="29.9" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="806"/>
                    <measurement group_id="B2" value="802"/>
                    <measurement group_id="B3" value="1608"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="772"/>
                    <measurement group_id="B2" value="775"/>
                    <measurement group_id="B3" value="1547"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="453"/>
                    <measurement group_id="B2" value="452"/>
                    <measurement group_id="B3" value="905"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="331"/>
                    <measurement group_id="B2" value="330"/>
                    <measurement group_id="B3" value="661"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="806"/>
                    <measurement group_id="B2" value="802"/>
                    <measurement group_id="B3" value="1608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>body mass index (kg/m^2)</description>
          <units>kg / m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.6" spread="7.7"/>
                    <measurement group_id="B2" value="39.5" spread="8.1"/>
                    <measurement group_id="B3" value="39.6" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)</title>
        <description>As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)</title>
          <description>As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)</title>
        <description>As defined according to the CDC's National Healthcare Safety Network criteria.</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)</title>
          <description>As defined according to the CDC's National Healthcare Safety Network criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)</title>
        <description>As defined according to the CDC's National Healthcare Safety Network criteria.</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)</title>
          <description>As defined according to the CDC's National Healthcare Safety Network criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)</title>
        <description>Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)</title>
          <description>Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).</title>
        <description>Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).</title>
          <description>Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Pain Score</title>
        <description>On a scale of 0 (least) - 10 (most).</description>
        <time_frame>At discharge, an average of 4 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Pain Score</title>
          <description>On a scale of 0 (least) - 10 (most).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Pain Score</title>
        <description>On a scale of 0 (least) - 10 (most).</description>
        <time_frame>At postoperative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Pain Score</title>
          <description>On a scale of 0 (least) - 10 (most).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction Score</title>
        <description>On a scale of 0 (least) - 10 (most).</description>
        <time_frame>At discharge, an average of 4 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction Score</title>
          <description>On a scale of 0 (least) - 10 (most).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="9" lower_limit="7" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction Score</title>
        <description>On a scale of 0 (least) - 10 (most).</description>
        <time_frame>At postoperative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction Score</title>
          <description>On a scale of 0 (least) - 10 (most).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="9" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)</title>
        <description>Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)</title>
          <description>Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)</title>
        <description>Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).</description>
        <time_frame>30 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prophylactic NPWT</title>
            <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)</title>
          <description>Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="806"/>
                <count group_id="O2" value="802"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus</title>
        <description>Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus.</description>
        <time_frame>30 days postoperatively</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incremental Cost Per SSI Prevented</title>
        <description>Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.</description>
        <time_frame>30 days postoperatively</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incremental Cost Per Quality-Adjusted Life-year</title>
        <description>Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.</description>
        <time_frame>30 days postoperatively</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Risk Factors for Surgical Site Infections in Obese Women</title>
        <description>Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.</description>
        <time_frame>30 days postoperatively</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>Occurring within data collection period, to be reported within 24 hours of learning of the event:&#xD;
Serious Adverse Events - Death or Life-threatening situations:&#xD;
Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission&#xD;
Abnormal findings in labs or assessments will not be reported as adverse events.&#xD;
Adverse Events of special interest will be reported - mild/moderate reactions:&#xD;
Skin blisters Wound bleeding Allergic skin reaction</desc>
      <group_list>
        <group group_id="E1">
          <title>Prophylactic NPWT</title>
          <description>Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.&#xD;
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.</description>
        </group>
        <group group_id="E2">
          <title>Standard Dressing</title>
          <description>Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.&#xD;
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="806"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="802"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="806"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Maternal Sepsis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="806"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Postpartum hysterectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Maternal ICU admission</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="806"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="806"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="806"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blisters</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="806"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="802"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="806"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="802"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="806"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="802"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The trial was stopped following a planned interim analysis, raising the possibility that it may be underpowered.&#xD;
The clinical team could not be blinded to the intervention, raising the possibility of bias.&#xD;
No adjustment was made for multiple comparisons, thus secondary end points could have occurred by chance.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Graham Hogg</name_or_title>
      <organization>Indiana University School of Medicine</organization>
      <phone>317-962-0415</phone>
      <email>gahogg@iu.edu</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/NCT03009110
org study id: IRB ID #: 201603062
secondary id: 1R01HD086007-01A1
nct id: NCT03009110
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large
      pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness,
      safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a
      closed, sealed system that applies negative pressure to the wound surface via a single-use,
      battery-powered, portable device - to decrease surgical site infections (SSIs) in obese
      women.
Experimental evidence suggests that NPWT promotes wound healing by removing exudate,
      approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index
      [BMI] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese
      women. The increased risk of SSIs is in part due to the increased thickness of the
      subcutaneous space, allowing collection of exudates and increasing tension on wound edges,
      promoting the growth of bacteria, and leading to wound infection and breakdown. Thus,
      prophylactic NPWT may be particularly effective in this patient population.

      During the 5-year project period, investigators from 4 collaborating perinatal centers in the
      United Stated (two university and two community) will randomize 2850 obese women undergoing
      cesarean delivery to receive either prophylactic negative pressure wound therapy with the
      Prevena device or standard wound dressing. Women will be followed up to 30 days
      postoperatively to ascertain study outcomes.

      The primary outcome for the trial is superficial or deep SSI after cesarean according to the
      CDC's National Healthcare Safety Network definitions. The investigators will also assess
      other wound complications, adverse events potentially attributable to NPWT and
      cost-effectiveness as measured by incremental cost per case of SSI prevented and per
      quality-adjusted life year (QALY).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)
time frame: 30 days postoperatively
description: As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.
measure: Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)
time frame: 30 days postoperatively
description: As defined according to the CDC's National Healthcare Safety Network criteria.
measure: Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)
time frame: 30 days postoperatively
description: As defined according to the CDC's National Healthcare Safety Network criteria.
measure: Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)
time frame: 30 days postoperatively
description: Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).
measure: Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).
time frame: 30 days postoperatively
description: Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).
measure: Patient Pain Score
time frame: At discharge, an average of 4 days postoperatively
description: On a scale of 0 (least) - 10 (most).
measure: Patient Pain Score
time frame: At postoperative day 30
description: On a scale of 0 (least) - 10 (most).
measure: Patient Satisfaction Score
time frame: At discharge, an average of 4 days postoperatively
description: On a scale of 0 (least) - 10 (most).
measure: Patient Satisfaction Score
time frame: At postoperative day 30
description: On a scale of 0 (least) - 10 (most).
measure: Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)
time frame: 30 days postoperatively
description: Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).
measure: Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)
time frame: 30 days postoperatively
description: Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).
measure: Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus
time frame: 30 days postoperatively
description: Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus.
measure: Incremental Cost Per SSI Prevented
time frame: 30 days postoperatively
description: Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
measure: Incremental Cost Per Quality-Adjusted Life-year
time frame: 30 days postoperatively
description: Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
measure: Risk Factors for Surgical Site Infections in Obese Women
time frame: 30 days postoperatively
description: Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.
arm group label: Prophylactic NPWT
arm group type: Experimental
description: Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.
arm group label: Standard Dressing
arm group type: Active Comparator
description: Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.
intervention type: Device
intervention name: Prophylactic NPWT
description: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.
arm group label: Prophylactic NPWT
other name: Prevena
intervention type: Device
intervention name: Standard Dressing
description: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
arm group label: Standard Dressing
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Methodius G Tuuli, MD, MPH
role: Principal Investigator
affiliation: Indiana University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.
PMID: 24056202
citation: Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 2015 May-Jun;60(5-6):211-8.
PMID: 26126306
citation: Bullough, L, Wilkinson, D., Burns, S, Wan, L, Changing wound care protocols to reduce postoperative caesarean section infection and readmission, Wounds , 2014 (10), 1 : 72 - 76. 46
citation: Chaboyer W, Anderson V, Webster J, Sneddon A, Thalib L, Gillespie BM. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel). 2014 Sep 30;2(4):417-28. doi: 10.3390/healthcare2040417.
PMID: 27429285
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: David Haas
investigator title: Professor of Obstetrics and Gynecology
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Surgical Wound
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The trial was stopped following a planned interim analysis, raising the possibility that it may be underpowered.
The clinical team could not be blinded to the intervention, raising the possibility of bias.
No adjustment was made for multiple comparisons, thus secondary end points could have occurred by chance.
point of contact: 