<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/NCT02255487</url>
  </required_header>
  <id_info>
    <org_study_id>IRR-CT-901-2013-01</org_study_id>
    <nct_id>NCT02255487</nct_id>
  </id_info>
  <brief_title>Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections</brief_title>
  <official_title>A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Irrimax Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Irrimax Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to compare the rate of surgical site infections in patients&#xD;
      randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma&#xD;
      or acute surgical abdomen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial was explained to potential subjects, the informed consent was completed and and&#xD;
      eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an&#xD;
      open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal&#xD;
      trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed&#xD;
      approximately 30 days later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated early after the Interim Analysis due, in part, to issues with the&#xD;
    accuracy and completeness of the data collected.&#xD;
  </why_stopped>
  <start_date type="Actual">February 18, 2015</start_date>
  <completion_date type="Actual">March 13, 2017</completion_date>
  <primary_completion_date type="Actual">March 13, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The randomization methodology was controlled by the site.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Subjects With Surgical Site Infections (SSI)</measure>
    <time_frame>30 (+/- 3) days post-surgical procedure</time_frame>
    <description>The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Readmission Rates</measure>
    <time_frame>30 (+/- 3) days post-surgical procedure</time_frame>
    <description>A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Costs</measure>
    <time_frame>0 days</time_frame>
    <description>A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>30 (+/- 3) days post-surgical procedure</time_frame>
    <description>A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">627</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>IrriSept System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SoC) only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IrriSept System</intervention_name>
    <description>The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation.&#xD;
Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation.</description>
    <arm_group_label>IrriSept System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention - Standard of Care (SoC) only</intervention_name>
    <description>Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.</description>
    <arm_group_label>Standard of Care (SoC) only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is male or female, 18 years of age or older&#xD;
&#xD;
          2. Has provided written informed consent or has surrogate consent provided by a Legally&#xD;
             Authorized Representative (LAR)&#xD;
&#xD;
          3. Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal&#xD;
             laparotomy with primary closure or&#xD;
&#xD;
          4. Has experienced acute surgical abdomen requiring open abdominal laparotomy with&#xD;
             primary closure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy to Chlorhexidine Gluconate (CHG)&#xD;
&#xD;
          2. Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for&#xD;
             all trauma patients&#xD;
&#xD;
          3. American Society of Anesthesiologists Physical Status Classification (ASA) score of&#xD;
             five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the&#xD;
             patient stable enough for study participation despite a score of 5, enrollment may&#xD;
             continue.)&#xD;
&#xD;
          4. Female volunteers who are pregnant and/or breast feeding&#xD;
&#xD;
          5. Damage control laparotomy&#xD;
&#xD;
          6. Abdominal incision created prior to operating room (i.e. incision made in trauma bay&#xD;
             to cross clamp the aorta)&#xD;
&#xD;
          7. Currently enrolled in an ongoing, interventional, randomized clinical trial&#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>Donald Fry, MD</last_name>
    <role>Study Director</role>
    <affiliation>Michael Pine Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Southern California, USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of South Florida, Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kentucky Research Foundation</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Maryland, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Cincinnati Health</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The MetroHealth System</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>73160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional One Health Research Institute</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Washington, Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>October 18, 2021</results_first_submitted>
  <results_first_submitted_qc>April 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2022</results_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</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>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</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>February 10, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT02255487/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From 2015 to 2017, patients with abdominal trauma or acute surgical abdomen were recruited from participating research sites' universities, hospitals and/or emergency departments.</recruitment_details>
      <pre_assignment_details>The planned sample size was 1100 screened, 650 completed &amp; 600 evaluated. However, the study was terminated early after the interim analysis due, in part, to issues with the accuracy and completeness of the data collected. There were 627 consented and 617 randomized subjects. The intent-to-treat (ITT) population was defined as all randomized subjects. Of these, 309 were randomized to Irrisept and 308 to Standard of Care.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Irrisept</title>
          <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.&#xD;
Irrisept consists of two containers: (1) a sterile bottle of 450 mL of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% sterile water and (2) a sterile bottle of 450 mL of sterile 0.9% normal saline.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care (SoC)</title>
          <description>For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="308"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent to Treat (mITT)</title>
              <participants_list>
                <participants group_id="P1" count="293">Within the ITT population, subjects with unknown age entries (modified ITT or mITT) were considered &quot;non-evaluable&quot; and excluded from the analysis. The mITT population was defined as patients 18 years of age or older.</participants>
                <participants group_id="P2" count="291">Within the ITT population, subjects with unknown age entries (modified ITT or mITT) were considered &quot;non-evaluable&quot; and excluded from the analysis. The mITT population was defined as patients 18 years of age or older.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
                <participants group_id="P2" count="230"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Irrisept</title>
          <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care (SoC)</title>
          <description>For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.</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="293"/>
            <count group_id="B2" value="291"/>
            <count group_id="B3" value="584"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Average Age (Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.1" spread="18.7"/>
                    <measurement group_id="B2" value="50.1" spread="17.1"/>
                    <measurement group_id="B3" value="49.6" spread="17.9"/>
                  </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="103"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="224"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White or Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="199"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <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>
              <title>Mixed Race</title>
              <category_list>
                <category>
                  <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>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="293"/>
                    <measurement group_id="B2" value="291"/>
                    <measurement group_id="B3" value="584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" spread="10.9"/>
                    <measurement group_id="B2" value="29.3" spread="12.2"/>
                    <measurement group_id="B3" value="29.2" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants By Surgical Case Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Acute Surgical Abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trauma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.7" spread="19.0"/>
                    <measurement group_id="B2" value="170.0" spread="14.4"/>
                    <measurement group_id="B3" value="171.4" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.2" spread="27.3"/>
                    <measurement group_id="B2" value="83.4" spread="25.8"/>
                    <measurement group_id="B3" value="84.3" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Subjects With Surgical Site Infections (SSI)</title>
        <description>The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.</description>
        <time_frame>30 (+/- 3) days post-surgical procedure</time_frame>
        <population>Data is from the percentage of subjects that reported an SSI for the mITT subject populations.</population>
        <group_list>
          <group group_id="O1">
            <title>Irrisept</title>
            <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SoC)</title>
            <description>For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects With Surgical Site Infections (SSI)</title>
          <description>The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.</description>
          <population>Data is from the percentage of subjects that reported an SSI for the mITT subject populations.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="293"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Readmission Rates</title>
        <description>A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.</description>
        <time_frame>30 (+/- 3) days post-surgical procedure</time_frame>
        <population>Data is from the percentage of subjects that reported hospital readmission, due to an SSI, for the mITT subject populations.</population>
        <group_list>
          <group group_id="O1">
            <title>Irrisept</title>
            <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SoC)</title>
            <description>For subjects randomized to the control group, any SoC irrigation solution, preferred by the site, was used during the surgical procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Readmission Rates</title>
          <description>A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.</description>
          <population>Data is from the percentage of subjects that reported hospital readmission, due to an SSI, for the mITT subject populations.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="293"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Costs</title>
        <description>A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.</description>
        <time_frame>0 days</time_frame>
        <population>No data was collected for either randomization group, towards this objective. Therefore, the success or failure of this endpoint was not assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Irrisept</title>
            <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SoC)</title>
            <description>For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Costs</title>
          <description>A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.</description>
          <population>No data was collected for either randomization group, towards this objective. Therefore, the success or failure of this endpoint was not assessed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.</description>
        <time_frame>30 (+/- 3) days post-surgical procedure</time_frame>
        <population>Data is from the average number of days in the hospital for the mITT subject populations.</population>
        <group_list>
          <group group_id="O1">
            <title>Irrisept</title>
            <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SoC)</title>
            <description>For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.</description>
          <population>Data is from the average number of days in the hospital for the mITT subject populations.</population>
          <units>number of 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="293"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="24.8"/>
                    <measurement group_id="O2" value="12.0" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were not collected.</time_frame>
      <desc>Adverse events were not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Irrisept</title>
          <description>For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care (SoC)</title>
          <description>For subjects randomized to the control group, any Standard of Care (SoC) irrigation solution, preferred by the site, was used during the surgical procedure.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chevy Brown, Clinical Trials Manager</name_or_title>
      <organization>Irrimax Corporation</organization>
      <phone>770-807-3355 ext 15</phone>
      <email>chevy.brown@irrisept.com</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/NCT02255487
org study id: IRR-CT-901-2013-01
nct id: NCT02255487
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study was to compare the rate of surgical site infections in patients
      randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma
      or acute surgical abdomen.
The trial was explained to potential subjects, the informed consent was completed and and
      eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an
      open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal
      trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed
      approximately 30 days later.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The randomization methodology was controlled by the site.
primary purpose: Other
masking: None (Open Label)
measure: Percent of Subjects With Surgical Site Infections (SSI)
time frame: 30 (+/- 3) days post-surgical procedure
description: The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
measure: Hospital Readmission Rates
time frame: 30 (+/- 3) days post-surgical procedure
description: A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
measure: Hospital Costs
time frame: 0 days
description: A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.
measure: Length of Hospital Stay
time frame: 30 (+/- 3) days post-surgical procedure
description: A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
arm group label: IrriSept System
arm group type: Experimental
description: IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
arm group label: Standard of Care (SoC) only
arm group type: Active Comparator
description: Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
intervention type: Device
intervention name: IrriSept System
description: The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation.
Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation.
arm group label: IrriSept System
intervention type: Other
intervention name: No Intervention - Standard of Care (SoC) only
description: Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
arm group label: Standard of Care (SoC) only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donald Fry, MD
role: Study Director
affiliation: Michael Pine Associates
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 