<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/NCT03269968</url>
  </required_header>
  <id_info>
    <org_study_id>2017-137</org_study_id>
    <nct_id>NCT03269968</nct_id>
  </id_info>
  <brief_title>Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery</brief_title>
  <official_title>Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amenity Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medstar Health Research Institute</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obese women are more likely have a cesarean delivery and develop subsequent wound&#xD;
      complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown&#xD;
      to improve surgical wound healing, but this device has not been adequately studied in&#xD;
      cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly&#xD;
      obese women after cesarean delivery.&#xD;
&#xD;
      Investigators will be randomizing women with a BMI &gt; 40 kg/m2 in a 1:1 ratio to either NPWT&#xD;
      (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their&#xD;
      cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a&#xD;
      minimum of four days but not to exceed seven days. The standard dressing is typically removed&#xD;
      on postoperative day one or two. The primary outcome is a wound complication defined as the&#xD;
      formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to&#xD;
      4 weeks postpartum. Investigators will also administer a patient satisfaction survey&#xD;
      regarding their wound healing experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obese women are more likely to be delivered by cesarean than normal weight women and are at&#xD;
      increased risk for operative morbidity including wound complications. Negative pressure wound&#xD;
      therapy (NPWT) has been shown to improve wound healing, decrease the rate of surgical site&#xD;
      infection, sero-hematoma formation, and reoperation rates. The potential benefit of NPWT in&#xD;
      high-risk wounds after cesarean delivery is unclear. Investigators propose conducting a&#xD;
      single-site randomized controlled trial to examine the efficacy of NPWT after cesarean&#xD;
      delivery in morbidly obese women (BMI ≥ 40 kg/m2).&#xD;
&#xD;
      Specific aims of the study include determining if NPWT used in morbidly obese women after&#xD;
      cesarean delivery improves postoperative wound complication rate and to assess patient&#xD;
      satisfaction with NPWT. The primary outcome is a composite wound complication rate defined as&#xD;
      having one of the following occur within four weeks of delivery: wound infection, seroma,&#xD;
      hematoma, separation, or dehiscence.&#xD;
&#xD;
      Participants will be randomized in a 1:1 ratio to either NPWT or standard surgical dressing.&#xD;
      Women receiving NWPT will have a PREVENA Incision Management Therapy System applied directly&#xD;
      onto their skin over the closed incision after delivery. Women randomized to the standard&#xD;
      surgical dressing will have a TELFA non-adhesive dressing with a 3M Tegaderm transparent film&#xD;
      adhesive dressing. In addition, an abdominal pad (ABD) with foam tape may be applied to&#xD;
      provide additional pressure if needed.&#xD;
&#xD;
      The wound will be assessed at the time of dressing removal or hospital discharge and at four&#xD;
      weeks postoperative. Participants will also take a patient satisfaction survey regarding&#xD;
      wound healing experience at four-week follow-up. For the study, investigators are planning to&#xD;
      enroll 482 patients (241 per arm) to demonstrate a decrease in the wound complication rate by&#xD;
      50%. This study will help clinicians better manage obese women in pregnancy and hopefully&#xD;
      improve wound outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment difficulty&#xD;
  </why_stopped>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 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>
    <intervention_model_description>Study participants will be enrolled in a 1:1 ratio to either Negative Pressure Wound Therapy or standard dressing. Randomization will occur prior to delivery using a computer randomization system.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Wound Complication</measure>
    <time_frame>Four weeks postpartum</time_frame>
    <description>Any of wound infection, seroma/hematoma, wound separation &gt;1 cm, and wound dehiscence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Survey</measure>
    <time_frame>Four weeks postpartum</time_frame>
    <description>Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Demographic Data</measure>
    <time_frame>At time time of admission</time_frame>
    <description>Age, race/ethnicity, parity</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Body Mass Index</measure>
    <time_frame>At time time of admission</time_frame>
    <description>Prepregnancy and at the time of delivery</description>
  </other_outcome>
  <other_outcome>
    <measure>Gestational Age at Delivery</measure>
    <time_frame>At time time of admission</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Comorbidities</measure>
    <time_frame>At time time of admission</time_frame>
    <description>Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism</description>
  </other_outcome>
  <other_outcome>
    <measure>Antenatal Complications</measure>
    <time_frame>At time time of admission</time_frame>
    <description>Gestational diabetes, preeclampsia</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Previous Cesarean Deliveries</measure>
    <time_frame>At time time of admission</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Indication for Cesarean Delivery</measure>
    <time_frame>At time time of cesarean delivery</time_frame>
    <description>Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean</description>
  </other_outcome>
  <other_outcome>
    <measure>Reason for Admission</measure>
    <time_frame>At the time of admission</time_frame>
    <description>Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)</description>
  </other_outcome>
  <other_outcome>
    <measure>Labor Duration</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Endometritis</measure>
    <time_frame>Four weeks postpartum</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of Rupture of Membranes</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Operative Time</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intraoperative Complication</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of Skin Incision</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of Uterine Incision</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of Fascia Closure</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of Subcutaneous Closure</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Administration of Preoperative Antibiotics</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other</description>
  </other_outcome>
  <other_outcome>
    <measure>Quantitative Blood Loss</measure>
    <time_frame>At the time of cesarean delivery</time_frame>
    <description>We were unable to adequately recruit for this study. Study was closed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Wound Infection</condition>
  <condition>Wound Complication</condition>
  <arm_group>
    <arm_group_label>Negative pressure wound therapy (NPWT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard dressing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard dressing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Negative pressure wound therapy (PREVENA Incision Management Therapy System)</intervention_name>
    <description>After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.</description>
    <arm_group_label>Negative pressure wound therapy (NPWT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard dressing</intervention_name>
    <description>After cesarean delivery, women in the intervention group will receive standard dressing.</description>
    <arm_group_label>Standard dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index ≥40 kg/m2 at time of delivery&#xD;
&#xD;
          -  Delivered by cesarean delivery&#xD;
&#xD;
          -  18 years or later&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chorioamnionitis&#xD;
&#xD;
          -  Silver allergy&#xD;
&#xD;
          -  Inability to follow up&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachael T Overcash, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Washington Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Iqbal N Iqbal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Washington Hospital Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>September 24, 2020</results_first_submitted>
  <results_first_submitted_qc>September 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2020</results_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03269968/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was terminated due to insufficient enrollment. No study data are available.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Negative Pressure Wound Therapy (NPWT)</title>
          <description>Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.&#xD;
Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.</description>
        </group>
        <group group_id="P2">
          <title>Standard Dressing</title>
          <description>Standard dressing&#xD;
Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study was terminated due to insufficient enrollment. No study data are available.</population>
      <group_list>
        <group group_id="B1">
          <title>Negative Pressure Wound Therapy (NPWT)</title>
          <description>Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.&#xD;
Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.</description>
        </group>
        <group group_id="B2">
          <title>Standard Dressing</title>
          <description>Standard dressing&#xD;
Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.</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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Composite Wound Complication</title>
        <description>Any of wound infection, seroma/hematoma, wound separation &gt;1 cm, and wound dehiscence</description>
        <time_frame>Four weeks postpartum</time_frame>
        <population>The study was terminated due to insufficient enrollment. No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Pressure Wound Therapy (NPWT)</title>
            <description>Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.&#xD;
Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Standard dressing&#xD;
Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Wound Complication</title>
          <description>Any of wound infection, seroma/hematoma, wound separation &gt;1 cm, and wound dehiscence</description>
          <population>The study was terminated due to insufficient enrollment. No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Survey</title>
        <description>Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.</description>
        <time_frame>Four weeks postpartum</time_frame>
        <population>The study was terminated due to insufficient enrollment. No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Negative Pressure Wound Therapy (NPWT)</title>
            <description>Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.&#xD;
Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.</description>
          </group>
          <group group_id="O2">
            <title>Standard Dressing</title>
            <description>Standard dressing&#xD;
Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Survey</title>
          <description>Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.</description>
          <population>The study was terminated due to insufficient enrollment. No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Demographic Data</title>
        <description>Age, race/ethnicity, parity</description>
        <time_frame>At time time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Body Mass Index</title>
        <description>Prepregnancy and at the time of delivery</description>
        <time_frame>At time time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Gestational Age at Delivery</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At time time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maternal Comorbidities</title>
        <description>Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism</description>
        <time_frame>At time time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Antenatal Complications</title>
        <description>Gestational diabetes, preeclampsia</description>
        <time_frame>At time time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Previous Cesarean Deliveries</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At time time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Indication for Cesarean Delivery</title>
        <description>Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean</description>
        <time_frame>At time time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Reason for Admission</title>
        <description>Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)</description>
        <time_frame>At the time of admission</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Labor Duration</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Endometritis</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>Four weeks postpartum</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Rupture of Membranes</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Operative Time</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Intraoperative Complication</title>
        <description>Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Type of Skin Incision</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Type of Uterine Incision</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Type of Fascia Closure</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Type of Subcutaneous Closure</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Administration of Preoperative Antibiotics</title>
        <description>Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Quantitative Blood Loss</title>
        <description>We were unable to adequately recruit for this study. Study was closed.</description>
        <time_frame>At the time of cesarean delivery</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The study was terminated due to insufficient enrollment. No study data are available.</time_frame>
      <desc>The study was terminated due to insufficient enrollment. No study data are available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Negative Pressure Wound Therapy (NPWT)</title>
          <description>Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.&#xD;
Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.</description>
        </group>
        <group group_id="E2">
          <title>Standard Dressing</title>
          <description>Standard dressing&#xD;
Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <point_of_contact>
      <name_or_title>Rachael Overcash</name_or_title>
      <organization>MedStar Health Reseach Institute</organization>
      <phone>202-877-6093</phone>
      <email>rachael.overcash@medstar.net</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/NCT03269968
org study id: 2017-137
nct id: NCT03269968
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Obese women are more likely have a cesarean delivery and develop subsequent wound
      complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown
      to improve surgical wound healing, but this device has not been adequately studied in
      cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly
      obese women after cesarean delivery.

      Investigators will be randomizing women with a BMI > 40 kg/m2 in a 1:1 ratio to either NPWT
      (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their
      cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a
      minimum of four days but not to exceed seven days. The standard dressing is typically removed
      on postoperative day one or two. The primary outcome is a wound complication defined as the
      formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to
      4 weeks postpartum. Investigators will also administer a patient satisfaction survey
      regarding their wound healing experience.
Obese women are more likely to be delivered by cesarean than normal weight women and are at
      increased risk for operative morbidity including wound complications. Negative pressure wound
      therapy (NPWT) has been shown to improve wound healing, decrease the rate of surgical site
      infection, sero-hematoma formation, and reoperation rates. The potential benefit of NPWT in
      high-risk wounds after cesarean delivery is unclear. Investigators propose conducting a
      single-site randomized controlled trial to examine the efficacy of NPWT after cesarean
      delivery in morbidly obese women (BMI ≥ 40 kg/m2).

      Specific aims of the study include determining if NPWT used in morbidly obese women after
      cesarean delivery improves postoperative wound complication rate and to assess patient
      satisfaction with NPWT. The primary outcome is a composite wound complication rate defined as
      having one of the following occur within four weeks of delivery: wound infection, seroma,
      hematoma, separation, or dehiscence.

      Participants will be randomized in a 1:1 ratio to either NPWT or standard surgical dressing.
      Women receiving NWPT will have a PREVENA Incision Management Therapy System applied directly
      onto their skin over the closed incision after delivery. Women randomized to the standard
      surgical dressing will have a TELFA non-adhesive dressing with a 3M Tegaderm transparent film
      adhesive dressing. In addition, an abdominal pad (ABD) with foam tape may be applied to
      provide additional pressure if needed.

      The wound will be assessed at the time of dressing removal or hospital discharge and at four
      weeks postoperative. Participants will also take a patient satisfaction survey regarding
      wound healing experience at four-week follow-up. For the study, investigators are planning to
      enroll 482 patients (241 per arm) to demonstrate a decrease in the wound complication rate by
      50%. This study will help clinicians better manage obese women in pregnancy and hopefully
      improve wound outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study participants will be enrolled in a 1:1 ratio to either Negative Pressure Wound Therapy or standard dressing. Randomization will occur prior to delivery using a computer randomization system.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Composite Wound Complication
time frame: Four weeks postpartum
description: Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence
measure: Patient Survey
time frame: Four weeks postpartum
description: Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.
measure: Demographic Data
time frame: At time time of admission
description: Age, race/ethnicity, parity
measure: Maternal Body Mass Index
time frame: At time time of admission
description: Prepregnancy and at the time of delivery
measure: Gestational Age at Delivery
time frame: At time time of admission
description: We were unable to adequately recruit for this study. Study was closed.
measure: Maternal Comorbidities
time frame: At time time of admission
description: Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism
measure: Antenatal Complications
time frame: At time time of admission
description: Gestational diabetes, preeclampsia
measure: Number of Previous Cesarean Deliveries
time frame: At time time of admission
description: We were unable to adequately recruit for this study. Study was closed.
measure: Indication for Cesarean Delivery
time frame: At time time of cesarean delivery
description: Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean
measure: Reason for Admission
time frame: At the time of admission
description: Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)
measure: Labor Duration
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Endometritis
time frame: Four weeks postpartum
description: We were unable to adequately recruit for this study. Study was closed.
measure: Length of Rupture of Membranes
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Operative Time
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Intraoperative Complication
time frame: At the time of cesarean delivery
description: Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy
measure: Type of Skin Incision
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Type of Uterine Incision
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Type of Fascia Closure
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Type of Subcutaneous Closure
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
measure: Administration of Preoperative Antibiotics
time frame: At the time of cesarean delivery
description: Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other
measure: Quantitative Blood Loss
time frame: At the time of cesarean delivery
description: We were unable to adequately recruit for this study. Study was closed.
arm group label: Negative pressure wound therapy (NPWT)
arm group type: Experimental
description: Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.
arm group label: Standard dressing
arm group type: Placebo Comparator
description: Standard dressing
intervention type: Device
intervention name: Negative pressure wound therapy (PREVENA Incision Management Therapy System)
description: After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.
arm group label: Negative pressure wound therapy (NPWT)
intervention type: Device
intervention name: Standard dressing
description: After cesarean delivery, women in the intervention group will receive standard dressing.
arm group label: Standard dressing
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Rachael T Overcash, MD, MPH
role: Principal Investigator
affiliation: Medstar Washington Hospital Center
last name: Iqbal N Iqbal, MD
role: Principal Investigator
affiliation: Medstar Washington Hospital Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Obesity, Morbid
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 