<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/NCT02186457</url>
  </required_header>
  <id_info>
    <org_study_id>1403644165</org_study_id>
    <nct_id>NCT02186457</nct_id>
  </id_info>
  <brief_title>Antibiotic Irrigation for Pancreatoduodenectomy</brief_title>
  <official_title>Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the routine use of antibiotic irrigation during&#xD;
      pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to test the efficacy of routine antibiotic irrigation in&#xD;
      reducing superficial and organ space infections among patients undergoing&#xD;
      pancreatoduodenectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">April 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Patients With Infections</measure>
    <time_frame>30 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Patients With Fistulas</measure>
    <time_frame>5 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Surgery</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Polymyxin B in Normal Saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo: Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9 % Normal Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polymyxin B in Normal Saline</intervention_name>
    <description>Antibiotic irrigation via peritoneal lavage</description>
    <arm_group_label>Polymyxin B in Normal Saline</arm_group_label>
    <other_name>Antibiotic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo: Normal Saline</intervention_name>
    <description>Placebo irrigation via peritoneal lavage</description>
    <arm_group_label>Placebo: Normal Saline</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age and older;&#xD;
&#xD;
          -  Open pancreatoduodenectomy for any diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant;&#xD;
&#xD;
          -  Prisoners;&#xD;
&#xD;
          -  Patients undergoing concomitant colectomy;&#xD;
&#xD;
          -  Antibiotic allergy to study medication;&#xD;
&#xD;
          -  Serum creatinine &gt; 2.0;&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>88 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael House, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>August 14, 2019</results_first_submitted>
  <results_first_submitted_qc>January 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2022</results_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Michael G. House</investigator_full_name>
    <investigator_title>Associate Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Pancreatoduodenectomy</keyword>
  <keyword>Whipple</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Polymyxins</mesh_term>
    <mesh_term>Polymyxin B</mesh_term>
  </intervention_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>October 31, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT02186457/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>more patients enrolled</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Polymyxin B in Normal Saline</title>
          <description>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline&#xD;
Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage</description>
        </group>
        <group group_id="P2">
          <title>Placebo: Normal Saline</title>
          <description>0.9 % Normal Saline&#xD;
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="95"/>
              </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>Polymyxin B in Normal Saline</title>
          <description>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline&#xD;
Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage</description>
        </group>
        <group group_id="B2">
          <title>Placebo: Normal Saline</title>
          <description>0.9 % Normal Saline&#xD;
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage</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="95"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="190"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age distribution</title>
              <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="60"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.7" spread="1.3"/>
                    <measurement group_id="B2" value="64.4" spread="1.5"/>
                    <measurement group_id="B3" value="64.1" spread="1.4"/>
                  </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="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="112"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Patients With Infections</title>
        <time_frame>30 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polymyxin B in Normal Saline</title>
            <description>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline&#xD;
Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage</description>
          </group>
          <group group_id="O2">
            <title>Placebo: Normal Saline</title>
            <description>0.9 % Normal Saline&#xD;
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Infections</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Patients With Fistulas</title>
        <time_frame>5 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polymyxin B in Normal Saline</title>
            <description>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline&#xD;
Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage</description>
          </group>
          <group group_id="O2">
            <title>Placebo: Normal Saline</title>
            <description>0.9 % Normal Saline&#xD;
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Fistulas</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Polymyxin B in Normal Saline</title>
          <description>Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline&#xD;
Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage</description>
        </group>
        <group group_id="E2">
          <title>Placebo: Normal Saline</title>
          <description>0.9 % Normal Saline&#xD;
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage</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="1" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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>Dr. Michael House</name_or_title>
      <organization>Indiana University School of Medicine</organization>
      <phone>3179440113</phone>
      <email>michouse@iupui.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/NCT02186457
org study id: 1403644165
nct id: NCT02186457
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if the routine use of antibiotic irrigation during
      pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.
The primary aim of this study is to test the efficacy of routine antibiotic irrigation in
      reducing superficial and organ space infections among patients undergoing
      pancreatoduodenectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The Number of Patients With Infections
time frame: 30 Days
measure: The Number of Patients With Fistulas
time frame: 5 Days
arm group label: Polymyxin B in Normal Saline
arm group type: Experimental
description: Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline
arm group label: Placebo: Normal Saline
arm group type: Placebo Comparator
description: 0.9 % Normal Saline
intervention type: Drug
intervention name: Polymyxin B in Normal Saline
description: Antibiotic irrigation via peritoneal lavage
arm group label: Polymyxin B in Normal Saline
other name: Antibiotic
intervention type: Other
intervention name: Placebo: Normal Saline
description: Placebo irrigation via peritoneal lavage
arm group label: Placebo: Normal Saline
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 88 Years
healthy volunteers: No
last name: Michael House, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Michael G. House
investigator title: Associate Professor of Surgery
mesh term: Infections
mesh term: Anti-Bacterial Agents
mesh term: Polymyxins
mesh term: Polymyxin B
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 