<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/NCT03010137</url>
  </required_header>
  <id_info>
    <org_study_id>801708</org_study_id>
    <nct_id>NCT03010137</nct_id>
  </id_info>
  <brief_title>Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial</brief_title>
  <official_title>Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incisional negative pressure therapy (INPWT) has previously been shown in certain patient&#xD;
      populations to decrease wound healing complications, decrease the rate of hematomas and&#xD;
      seromas, as well as have better scar quality. We have found a group of patients, those who&#xD;
      have panniculectomies in preparation for renal transplant, with significantly higher rates of&#xD;
      wound healing complications. We believe the best way to demonstrate benefits of incisional&#xD;
      negative pressure wound therapy will be in this group of patients known to have significantly&#xD;
      higher rates of wound complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of staff resources to properly consent and enroll patients into the study.&#xD;
  </why_stopped>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">March 13, 2019</completion_date>
  <primary_completion_date type="Actual">March 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>Major Wound Healing Complications</measure>
    <time_frame>Up to 3 months after operation</time_frame>
    <description>Abscess, Hematoma or any wound complication requiring return to the operating room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minor Wound Healing Complications</measure>
    <time_frame>Up to 3 months after operation</time_frame>
    <description>Cellulitis, Seroma, Superficial Wound Separation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Drain Removal</measure>
    <time_frame>Up to 3 months after operation</time_frame>
    <description>Time to final drain removal after the operation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Scarring</measure>
    <time_frame>data not collected due to early termination</time_frame>
    <description>Will assess using Vancouver Scar Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Score Self Reported by the Patient After Surgery</measure>
    <time_frame>data not collected due to early termination</time_frame>
    <description>Assess via a visual analog scale at specified intervals</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life as Measured by SF-36 Validated Survey</measure>
    <time_frame>data not collected due to early termination</time_frame>
    <description>Assess via SF-36 validated survey at specified intervals</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Complications Wounds</condition>
  <condition>Negative Pressure Wound Therapy</condition>
  <condition>Wound Healing Delayed</condition>
  <condition>Incisional</condition>
  <condition>Panniculectomy</condition>
  <condition>Incisional Negative Pressure Wound Therapy</condition>
  <condition>Incisional Vac</condition>
  <condition>Wound Vac</condition>
  <condition>Obese</condition>
  <condition>Renal Failure</condition>
  <condition>Kidney Transplant; Complications</condition>
  <condition>Wound Healing Complication</condition>
  <arm_group>
    <arm_group_label>Standard Closure</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incisional Negative Pressure Wound Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Incisional Negative Pressure Wound Therapy</intervention_name>
    <arm_group_label>Incisional Negative Pressure Wound Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Closure with Skin Glue</intervention_name>
    <arm_group_label>Standard Closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICO (Smith&amp;Nephew)</intervention_name>
    <description>Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
    <arm_group_label>Incisional Negative Pressure Wound Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dermabond</intervention_name>
    <description>Final wound closure with skin glue.</description>
    <arm_group_label>Standard Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing panniculectomy in preparation for renal transplantation at the&#xD;
             University of California Davis Medical Center. Patients who are entered into the trial&#xD;
             and have 30 days of follow up, and those in the INPWT study arm who successfully&#xD;
             complete 7 days of treatment, will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients who previously demonstrated a hypersensitivity reaction to adhesives and&#xD;
             qualify for panniculectomy in preparation for renal transplantation, or all patients&#xD;
             who are undergoing panniculectomy for reasons other than in preparation for renal&#xD;
             transplantation (i.e. after massive weight loss or for cosmetic reasons). Patients who&#xD;
             do not complete the duration of treatment of negative pressure wound therapy (7 days),&#xD;
             or patients who do not follow up for a minimum of 30 days from the date of surgery&#xD;
             will be excluded. Adults unable to consent, infants, children, teenagers, pregnant&#xD;
             patients and prisoners will be excluded. It is also extremely unlikely, based on our&#xD;
             study population, that we will encounter any of these patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S Wong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <results_first_submitted>March 26, 2020</results_first_submitted>
  <results_first_submitted_qc>May 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <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>October 25, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03010137/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>March 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03010137/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard Closure</title>
          <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
        </group>
        <group group_id="P2">
          <title>Incisional Negative Pressure Wound Therapy</title>
          <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Standard Closure</title>
          <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
        </group>
        <group group_id="B2">
          <title>Incisional Negative Pressure Wound Therapy</title>
          <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" spread="8.6"/>
                    <measurement group_id="B2" value="57" spread="10"/>
                    <measurement group_id="B3" value="55.6" spread="12.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Major Wound Healing Complications</title>
        <description>Abscess, Hematoma or any wound complication requiring return to the operating room.</description>
        <time_frame>Up to 3 months after operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Closure</title>
            <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
          </group>
          <group group_id="O2">
            <title>Incisional Negative Pressure Wound Therapy</title>
            <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Wound Healing Complications</title>
          <description>Abscess, Hematoma or any wound complication requiring return to the operating room.</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="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Minor Wound Healing Complications</title>
        <description>Cellulitis, Seroma, Superficial Wound Separation</description>
        <time_frame>Up to 3 months after operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Closure</title>
            <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
          </group>
          <group group_id="O2">
            <title>Incisional Negative Pressure Wound Therapy</title>
            <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
          </group>
        </group_list>
        <measure>
          <title>Minor Wound Healing Complications</title>
          <description>Cellulitis, Seroma, Superficial Wound Separation</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="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Drain Removal</title>
        <description>Time to final drain removal after the operation</description>
        <time_frame>Up to 3 months after operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Closure</title>
            <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
          </group>
          <group group_id="O2">
            <title>Incisional Negative Pressure Wound Therapy</title>
            <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Drain Removal</title>
          <description>Time to final drain removal after the operation</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="14.1"/>
                    <measurement group_id="O2" value="24" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scarring</title>
        <description>Will assess using Vancouver Scar Scale</description>
        <time_frame>data not collected due to early termination</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Score Self Reported by the Patient After Surgery</title>
        <description>Assess via a visual analog scale at specified intervals</description>
        <time_frame>data not collected due to early termination</time_frame>
        <population>Unable to perform final analysis due to early closure of the study</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Closure</title>
            <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
          </group>
          <group group_id="O2">
            <title>Incisional Negative Pressure Wound Therapy</title>
            <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score Self Reported by the Patient After Surgery</title>
          <description>Assess via a visual analog scale at specified intervals</description>
          <population>Unable to perform final analysis due to early closure of the study</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>Quality of Life as Measured by SF-36 Validated Survey</title>
        <description>Assess via SF-36 validated survey at specified intervals</description>
        <time_frame>data not collected due to early termination</time_frame>
        <population>unable to perform final analysis due to early termination of study</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Closure</title>
            <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
          </group>
          <group group_id="O2">
            <title>Incisional Negative Pressure Wound Therapy</title>
            <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Measured by SF-36 Validated Survey</title>
          <description>Assess via SF-36 validated survey at specified intervals</description>
          <population>unable to perform final analysis due to early termination of study</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_list>

    <reported_events>
      <time_frame>6 months period following panniculectomy surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard Closure</title>
          <description>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).&#xD;
Standard Closure with Skin Glue&#xD;
Dermabond: Final wound closure with skin glue.</description>
        </group>
        <group group_id="E2">
          <title>Incisional Negative Pressure Wound Therapy</title>
          <description>After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.&#xD;
Incisional Negative Pressure Wound Therapy&#xD;
PICO (Smith&amp;Nephew): Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Yunfeng Xue</name_or_title>
      <organization>UC Davis Medical Center</organization>
      <phone>408-603-0507</phone>
      <email>yunxue@ucdavis.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/NCT03010137
org study id: 801708
nct id: NCT03010137
lead sponsor: 
has dmc: No
Incisional negative pressure therapy (INPWT) has previously been shown in certain patient
      populations to decrease wound healing complications, decrease the rate of hematomas and
      seromas, as well as have better scar quality. We have found a group of patients, those who
      have panniculectomies in preparation for renal transplant, with significantly higher rates of
      wound healing complications. We believe the best way to demonstrate benefits of incisional
      negative pressure wound therapy will be in this group of patients known to have significantly
      higher rates of wound complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Major Wound Healing Complications
time frame: Up to 3 months after operation
description: Abscess, Hematoma or any wound complication requiring return to the operating room.
measure: Minor Wound Healing Complications
time frame: Up to 3 months after operation
description: Cellulitis, Seroma, Superficial Wound Separation
measure: Time to Drain Removal
time frame: Up to 3 months after operation
description: Time to final drain removal after the operation
measure: Scarring
time frame: data not collected due to early termination
description: Will assess using Vancouver Scar Scale
measure: Pain Score Self Reported by the Patient After Surgery
time frame: data not collected due to early termination
description: Assess via a visual analog scale at specified intervals
measure: Quality of Life as Measured by SF-36 Validated Survey
time frame: data not collected due to early termination
description: Assess via SF-36 validated survey at specified intervals
arm group label: Standard Closure
arm group type: Placebo Comparator
description: After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
arm group label: Incisional Negative Pressure Wound Therapy
arm group type: Active Comparator
description: After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.
intervention type: Procedure
intervention name: Incisional Negative Pressure Wound Therapy
arm group label: Incisional Negative Pressure Wound Therapy
intervention type: Procedure
intervention name: Standard Closure with Skin Glue
arm group label: Standard Closure
intervention type: Device
intervention name: PICO (Smith&Nephew)
description: Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.
arm group label: Incisional Negative Pressure Wound Therapy
intervention type: Device
intervention name: Dermabond
description: Final wound closure with skin glue.
arm group label: Standard Closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael S Wong, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 