<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/NCT03021668</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00109564</org_study_id>
    <nct_id>NCT03021668</nct_id>
  </id_info>
  <brief_title>Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections</brief_title>
  <official_title>A Randomized Control Trial of Prevena Peel &amp; Place Dressing Versus Standard Closure for Patients Undergoing Pancreaticoduodenectomy Who Have Undergone Neoadjuvant Chemotherapy or Biliary Stent Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site&#xD;
      infection (SSIs) being one of the most common complications. A retrospective study at Hopkins&#xD;
      on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile&#xD;
      stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site&#xD;
      infection. Patients with these factors having a predicted risk of up to 32%. Another&#xD;
      subsequent retrospective study demonstrated that the use of negative pressure wound therapy&#xD;
      device was significantly associated with a decrease in the rate of SSIs.&#xD;
&#xD;
      The hypothesis of the investigator(s) for the current study is that placement of Prevena Peel&#xD;
      &amp; Place Dressing (Negative Pressure Wound Therapy, NPWT) in patients undergoing&#xD;
      pancreaticoduodenectomy who are at high risk of SSIs will result in a significant decrease in&#xD;
      their SSI rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a&#xD;
      high perioperative complication rate. Surgical site infection is one of the most common&#xD;
      complications after pancreaticoduodenectomy. In a retrospective review of all patients who&#xD;
      underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679&#xD;
      patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis,&#xD;
      perioperative blood transfusion, operative time greater than 7 hours, preoperative&#xD;
      chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure&#xD;
      device, and vascular resection were associated with surgical site infection (all, p&lt;0.05). On&#xD;
      multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were&#xD;
      independent predictors of surgical site infection (all, p&lt;0.001). Studies in colorectal&#xD;
      patients have found an estimated cost of up to $1400 per patient secondary to prolonged&#xD;
      hospitalization, wound care, and wound complications in patients with procedures complicated&#xD;
      by a surgical site infection. Furthermore, in another study of 1144 patients undergoing&#xD;
      pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative&#xD;
      complications delayed time to adjuvant therapy, decreased median survival.&#xD;
&#xD;
      The hypothesis of the investigator(s) is that placement of Prevena Peel &amp; Place Dressing&#xD;
      using the standard Acelity vacuum dressing after suture on patients undergoing&#xD;
      pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in&#xD;
      surgical site infection rate. The investigator(s) plan to perform a randomized control trial&#xD;
      where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant&#xD;
      chemotherapy will undergo closure with Prevena Peel &amp; Place Dressing using the standard&#xD;
      Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then&#xD;
      follow the participant(s) for 30 days postoperatively to determine surgical site infection&#xD;
      and other perioperative complication rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>Rate of Surgical Site Infection</measure>
    <time_frame>Within 30 days of the operation</time_frame>
    <description>Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prolonged Length of Stay, Measured in Days</measure>
    <time_frame>Within 10 days of surgery</time_frame>
    <description>Length of stay of patient at the hospital from date of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Readmission for Surgical Site Infections (SSIs)</measure>
    <time_frame>Within 30 days of operation</time_frame>
    <description>Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-d Readmission</measure>
    <time_frame>Within 30 days of surgery</time_frame>
    <description>Need for 30-day readmission</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Chemotherapy Effects</condition>
  <condition>Chemoradiation</condition>
  <condition>Surgical Wound</condition>
  <condition>Wound Complication</condition>
  <arm_group>
    <arm_group_label>Prevena Peel &amp; Place Dressing for wound closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard closure of the wound</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prevena Peel &amp; Place Dressing</intervention_name>
    <description>Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
    <arm_group_label>Prevena Peel &amp; Place Dressing for wound closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Closure of the Surgical Incision</intervention_name>
    <description>This would involve standard closure of the incision site</description>
    <arm_group_label>Standard closure of the wound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient to undergo pancreaticoduodenectomy for pancreatic tumors at the Johns Hopkins&#xD;
             Hospital&#xD;
&#xD;
          -  Patient treated with neoadjuvant chemotherapy with or without radiation therapy prior&#xD;
             to surgical resection, AND/OR placement of a biliary stent and/or drain for biliary&#xD;
             tree decompression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or younger&#xD;
&#xD;
          -  Laparoscopic or robotic pancreaticoduodenectomy&#xD;
&#xD;
          -  Patient did not undergo either placement of a preoperative biliary stent/drain or&#xD;
             neoadjuvant chemotherapy with or without radiation therapy&#xD;
&#xD;
          -  All patients who are have known allergies or are sensitive to silver and acrylic&#xD;
             adhesives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew J Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>212187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>January 2, 2019</results_first_submitted>
  <results_first_submitted_qc>January 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 12, 2019</results_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Wounds and Injuries</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>April 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03021668/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
          <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
        </group>
        <group group_id="P2">
          <title>Standard Closure of the Wound</title>
          <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
          <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
        </group>
        <group group_id="B2">
          <title>Standard Closure of the Wound</title>
          <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</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="62"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="66.4" spread="9.3"/>
                    <measurement group_id="B2" value="66.1" spread="9.0"/>
                    <measurement group_id="B3" value="66.2" spread="9.1"/>
                  </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="31"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="65"/>
                  </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="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="102"/>
                  </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="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </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="62"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Neoadjuvant therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists (ASA) class</title>
          <description>The patients were graded according to the American Society of Anesthesiologists risk scoring system. Patients are scores between I and IV based on their operative risk.&#xD;
ASA I: A normal healthy patient. ASA II: A patient with a mild systemic disease. ASA III: A patient with a severe systemic disease that is not life-threatening. ASA IV: A patient with a severe systemic disease that is a constant threat to life.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ASA I/II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ASA III/IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preincisional prophylactic antibiotic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative biliary stenting</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Surgical Site Infection</title>
        <description>Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)</description>
        <time_frame>Within 30 days of the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
            <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
          </group>
          <group group_id="O2">
            <title>Standard Closure of the Wound</title>
            <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Surgical Site Infection</title>
          <description>Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)</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="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups</non_inferiority_desc>
            <p_value>0.003</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolonged Length of Stay, Measured in Days</title>
        <description>Length of stay of patient at the hospital from date of surgery</description>
        <time_frame>Within 10 days of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
            <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
          </group>
          <group group_id="O2">
            <title>Standard Closure of the Wound</title>
            <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</description>
          </group>
        </group_list>
        <measure>
          <title>Prolonged Length of Stay, Measured in Days</title>
          <description>Length of stay of patient at the hospital from date of surgery</description>
          <units>days</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="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="7" upper_limit="10"/>
                    <measurement group_id="O2" value="8" lower_limit="7" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Students' T-test was used to evaluate any difference in length of stay between the two groups.</non_inferiority_desc>
            <p_value>0.23</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Readmission for Surgical Site Infections (SSIs)</title>
        <description>Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery</description>
        <time_frame>Within 30 days of operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
            <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
          </group>
          <group group_id="O2">
            <title>Standard Closure of the Wound</title>
            <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Readmission for Surgical Site Infections (SSIs)</title>
          <description>Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery</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="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>30-d Readmission</title>
        <description>Need for 30-day readmission</description>
        <time_frame>Within 30 days of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
            <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
          </group>
          <group group_id="O2">
            <title>Standard Closure of the Wound</title>
            <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</description>
          </group>
        </group_list>
        <measure>
          <title>30-d Readmission</title>
          <description>Need for 30-day readmission</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="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Within 90 days of surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prevena Peel &amp; Place Dressing for Wound Closure</title>
          <description>In the participants randomized to this arm the surgical site will be closed using Prevena Peel &amp; Place Dressing.&#xD;
Prevena Peel &amp; Place Dressing: Prevena Peel &amp; Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound</description>
        </group>
        <group group_id="E2">
          <title>Standard Closure of the Wound</title>
          <description>In the participants randomized to this arm the surgical site will be closed using the standard closure technique.&#xD;
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site</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="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </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="7" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Delayed gastric emptying</sub_title>
                <description>Postoperative delayed gastric emptying</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="62"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative pancreatic fistula</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative respiratory complications</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="61"/>
              </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 study was conducted at a high volume center for pancreatic surgery with a broad experience using Negative-Pressure Wound Therapy (NPWT), and therefore there is a question about the generalizability of the reductions we observed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Matthew J. Weiss</name_or_title>
      <organization>Johns Hopkins Hospital</organization>
      <phone>4106143368</phone>
      <email>mweiss5@jhmi.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/NCT03021668
org study id: IRB00109564
nct id: NCT03021668
lead sponsor: 
has dmc: No
Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site
      infection (SSIs) being one of the most common complications. A retrospective study at Hopkins
      on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile
      stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site
      infection. Patients with these factors having a predicted risk of up to 32%. Another
      subsequent retrospective study demonstrated that the use of negative pressure wound therapy
      device was significantly associated with a decrease in the rate of SSIs.

      The hypothesis of the investigator(s) for the current study is that placement of Prevena Peel
      & Place Dressing (Negative Pressure Wound Therapy, NPWT) in patients undergoing
      pancreaticoduodenectomy who are at high risk of SSIs will result in a significant decrease in
      their SSI rate.
Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a
      high perioperative complication rate. Surgical site infection is one of the most common
      complications after pancreaticoduodenectomy. In a retrospective review of all patients who
      underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679
      patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis,
      perioperative blood transfusion, operative time greater than 7 hours, preoperative
      chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure
      device, and vascular resection were associated with surgical site infection (all, p<0.05). On
      multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were
      independent predictors of surgical site infection (all, p<0.001). Studies in colorectal
      patients have found an estimated cost of up to $1400 per patient secondary to prolonged
      hospitalization, wound care, and wound complications in patients with procedures complicated
      by a surgical site infection. Furthermore, in another study of 1144 patients undergoing
      pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative
      complications delayed time to adjuvant therapy, decreased median survival.

      The hypothesis of the investigator(s) is that placement of Prevena Peel & Place Dressing
      using the standard Acelity vacuum dressing after suture on patients undergoing
      pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in
      surgical site infection rate. The investigator(s) plan to perform a randomized control trial
      where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant
      chemotherapy will undergo closure with Prevena Peel & Place Dressing using the standard
      Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then
      follow the participant(s) for 30 days postoperatively to determine surgical site infection
      and other perioperative complication rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of Surgical Site Infection
time frame: Within 30 days of the operation
description: Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)
measure: Prolonged Length of Stay, Measured in Days
time frame: Within 10 days of surgery
description: Length of stay of patient at the hospital from date of surgery
measure: Rate of Readmission for Surgical Site Infections (SSIs)
time frame: Within 30 days of operation
description: Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery
measure: 30-d Readmission
time frame: Within 30 days of surgery
description: Need for 30-day readmission
arm group label: Prevena Peel & Place Dressing for wound closure
arm group type: Experimental
description: In the participants randomized to this arm the surgical site will be closed using Prevena Peel & Place Dressing.
arm group label: Standard closure of the wound
arm group type: Placebo Comparator
description: In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
intervention type: Device
intervention name: Prevena Peel & Place Dressing
description: Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
arm group label: Prevena Peel & Place Dressing for wound closure
intervention type: Other
intervention name: Standard Closure of the Surgical Incision
description: This would involve standard closure of the incision site
arm group label: Standard closure of the wound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew J Weiss, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Surgical Wound Infection
mesh term: Pancreatic Neoplasms
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was conducted at a high volume center for pancreatic surgery with a broad experience using Negative-Pressure Wound Therapy (NPWT), and therefore there is a question about the generalizability of the reductions we observed.
point of contact: 