<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/NCT02202577</url>
  </required_header>
  <id_info>
    <org_study_id>SPR-13-01063</org_study_id>
    <nct_id>NCT02202577</nct_id>
  </id_info>
  <brief_title>Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis</brief_title>
  <acronym>CAPICA</acronym>
  <official_title>Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior&#xD;
      to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean&#xD;
      related surgical site infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are considered likely to need cesarean delivery or who are planning cesarean&#xD;
      will be recruited and consented for study participation during prenatal care and/or at time&#xD;
      of admission to labor and delivery.&#xD;
&#xD;
      Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one&#xD;
      of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or 2.&#xD;
      Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting&#xD;
      surgeon (listed as key personnel) after the patient has arrived into the operating room for&#xD;
      cesarean. Pre-operative surgical site antisepsis will be performed according to&#xD;
      randomization. All other surgical practices will remain at the surgeon's discretion according&#xD;
      to standard of care at Metrohealth.&#xD;
&#xD;
      Patients will be examined daily by the obstetric team and evaluated for signs and symptoms of&#xD;
      surgical site infection, as standard in the investigators institution. The chart will be&#xD;
      reviewed to determine if the patient was diagnosed during admission, or, re-admitted because&#xD;
      of surgical site infection. The patient will also be questioned regarding any treatment or&#xD;
      diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the&#xD;
      routine six week post-operative visit. If patient does not return for the routine&#xD;
      post-operative visit, the investigator will attempt to contact the patient by telephone to&#xD;
      determine if the patient had been diagnosed or treated for surgical site infection. If&#xD;
      patient is lost to 6 week follow up, subanalysis will be performed on available data derived&#xD;
      from hospitalization and hospital Electronic Medical Record (EMR).&#xD;
&#xD;
      Data will be captured in RedCAP database.&#xD;
&#xD;
      Additional data will be captured that may affect patient likelihood of surgical site&#xD;
      infection to ensure that both groups are statistically equal in risk factors for SSI: labor&#xD;
      or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body Mass&#xD;
      Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes,&#xD;
      estimated blood loss, operative time, race, insurance type, general versus regional&#xD;
      anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples).&#xD;
&#xD;
      Power analysis was performed: assuming 7.5% risk of cesarean site infection and a 50%&#xD;
      reduction with chlorhexidine, 932 individuals will be recruited. Approximately 800 cesareans&#xD;
      are performed at the investigators institution per year and the investigators anticipate that&#xD;
      80% will be eligible to participate.&#xD;
&#xD;
      Data review will be done every 6 months or every 200 patients and analyzed, whichever is&#xD;
      sooner. Analysis will be performed by the Primary Investigators (PI) for completeness,&#xD;
      accuracy, strict adherence to study protocol, safety, and statistical significance. The&#xD;
      investigators site is also subject to periodic audits by the investigators Institutional&#xD;
      Review Board (IRB).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Surgical Site Infection</measure>
    <time_frame>4 weeks after cesarean delivery</time_frame>
    <description>Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Non-infections Surgical Site Complications</measure>
    <time_frame>4 weeks after cesarean delivery</time_frame>
    <description>Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">932</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine - Isopropyl alcohol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Povidone-Iodine Scrub and Paint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine - Isopropyl alcohol</intervention_name>
    <description>Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
    <arm_group_label>Chlorhexidine - Isopropyl alcohol</arm_group_label>
    <other_name>Chlora-Prep</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-Iodine Scrub and Paint</intervention_name>
    <description>Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
    <arm_group_label>Povidone-Iodine Scrub and Paint</arm_group_label>
    <other_name>Betadine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cesarean delivery&#xD;
&#xD;
          -  age 18-65&#xD;
&#xD;
          -  ability to consent in English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability or unwillingness to consent to study participation in English or Spanish&#xD;
&#xD;
          -  current incarceration&#xD;
&#xD;
          -  pre-operative diagnosis of chorioamnionitis&#xD;
&#xD;
          -  perceived inability to complete follow up for data collection&#xD;
&#xD;
          -  any prior known allergy or adverse reaction to either study preparation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian B Mercer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MetroHealth Medical Center/Case Western Reserve</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edward H Springel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MetroHealth Medical Center/Case Western Reserve</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109-1998</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.</citation>
    <PMID>20054046</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>January 13, 2022</results_first_submitted>
  <results_first_submitted_qc>July 18, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2022</results_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical site infection</keyword>
  <keyword>Surgical site antisepsis</keyword>
  <keyword>Cesarean Delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment and randomization began March 2014 and was successfully completed May 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Chlorhexidine - Isopropyl Alcohol</title>
          <description>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol&#xD;
Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
        </group>
        <group group_id="P2">
          <title>Povidone-Iodine Scrub and Paint</title>
          <description>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint&#xD;
Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="461"/>
                <participants group_id="P2" count="471"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="448"/>
                <participants group_id="P2" count="452"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chlorhexidine - Isopropyl Alcohol</title>
          <description>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol&#xD;
Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
        </group>
        <group group_id="B2">
          <title>Povidone-Iodine Scrub and Paint</title>
          <description>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint&#xD;
Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</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="461"/>
            <count group_id="B2" value="471"/>
            <count group_id="B3" value="932"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" lower_limit="24" upper_limit="33"/>
                    <measurement group_id="B2" value="28" lower_limit="24" upper_limit="32"/>
                    <measurement group_id="B3" value="28" lower_limit="24" upper_limit="32"/>
                  </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="461"/>
                    <measurement group_id="B2" value="471"/>
                    <measurement group_id="B3" value="932"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_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="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </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="207"/>
                    <measurement group_id="B2" value="210"/>
                    <measurement group_id="B3" value="417"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="368"/>
                  </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="69"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Surgical Site Infection</title>
        <description>Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.</description>
        <time_frame>4 weeks after cesarean delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine - Isopropyl Alcohol</title>
            <description>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol&#xD;
Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
          </group>
          <group group_id="O2">
            <title>Povidone-Iodine Scrub and Paint</title>
            <description>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint&#xD;
Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Surgical Site Infection</title>
          <description>Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.</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="461"/>
                <count group_id="O2" value="471"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="33"/>
                  </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>
            <groups_desc>We estimated a cesarean related surgical site infection rate of 7.5% with povidone-iodine and hypothesized chlorhexidine-alcohol treatment to be superior based on existing literature. We considered a 50% reduction to be significant. We performed our power analysis assuming&#xD;
1-directional effects in favor of chlorhexidine, which best fit our hypothesis. Using a 1-tailed alpha of 0.05 and an 80% power to detect a difference, we estimated that 466 subjects would be required in each group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.38</p_value>
            <p_value_desc>This is the calculated p-value for the intention to treat analysis of primary outcome. A 1-tailed p value of &lt;0.05 was selected for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Per Protocol Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <p_value_desc>This is the calculated p-value for the per protocol analysis of primary outcome. A 1-tailed p value of &lt;0.05 was selected for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Non-infections Surgical Site Complications</title>
        <description>Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.</description>
        <time_frame>4 weeks after cesarean delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine - Isopropyl Alcohol</title>
            <description>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol&#xD;
Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
          </group>
          <group group_id="O2">
            <title>Povidone-Iodine Scrub and Paint</title>
            <description>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint&#xD;
Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Non-infections Surgical Site Complications</title>
          <description>Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.</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="461"/>
                <count group_id="O2" value="471"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <desc>Adverse event data was collected at the same time as primary outcome data.</desc>
      <group_list>
        <group group_id="E1">
          <title>Chlorhexidine - Isopropyl Alcohol</title>
          <description>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol&#xD;
Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</description>
        </group>
        <group group_id="E2">
          <title>Povidone-Iodine Scrub and Paint</title>
          <description>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint&#xD;
Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA</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="461"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="461"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </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="461"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </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>Lack of masking of clinical personnel to treatment assignment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Edward H Springel, MD</name_or_title>
      <organization>Virginia Commonwealth University Health System</organization>
      <phone>804-828-8468</phone>
      <email>edward.springel@vcuhealth.org</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/NCT02202577
org study id: SPR-13-01063
nct id: NCT02202577
lead sponsor: 
has dmc: No
Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior
      to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean
      related surgical site infection.
Patients who are considered likely to need cesarean delivery or who are planning cesarean
      will be recruited and consented for study participation during prenatal care and/or at time
      of admission to labor and delivery.

      Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one
      of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or 2.
      Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting
      surgeon (listed as key personnel) after the patient has arrived into the operating room for
      cesarean. Pre-operative surgical site antisepsis will be performed according to
      randomization. All other surgical practices will remain at the surgeon's discretion according
      to standard of care at Metrohealth.

      Patients will be examined daily by the obstetric team and evaluated for signs and symptoms of
      surgical site infection, as standard in the investigators institution. The chart will be
      reviewed to determine if the patient was diagnosed during admission, or, re-admitted because
      of surgical site infection. The patient will also be questioned regarding any treatment or
      diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the
      routine six week post-operative visit. If patient does not return for the routine
      post-operative visit, the investigator will attempt to contact the patient by telephone to
      determine if the patient had been diagnosed or treated for surgical site infection. If
      patient is lost to 6 week follow up, subanalysis will be performed on available data derived
      from hospitalization and hospital Electronic Medical Record (EMR).

      Data will be captured in RedCAP database.

      Additional data will be captured that may affect patient likelihood of surgical site
      infection to ensure that both groups are statistically equal in risk factors for SSI: labor
      or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body Mass
      Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes,
      estimated blood loss, operative time, race, insurance type, general versus regional
      anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples).

      Power analysis was performed: assuming 7.5% risk of cesarean site infection and a 50%
      reduction with chlorhexidine, 932 individuals will be recruited. Approximately 800 cesareans
      are performed at the investigators institution per year and the investigators anticipate that
      80% will be eligible to participate.

      Data review will be done every 6 months or every 200 patients and analyzed, whichever is
      sooner. Analysis will be performed by the Primary Investigators (PI) for completeness,
      accuracy, strict adherence to study protocol, safety, and statistical significance. The
      investigators site is also subject to periodic audits by the investigators Institutional
      Review Board (IRB).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients With Surgical Site Infection
time frame: 4 weeks after cesarean delivery
description: Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.
measure: Number of Patients With Non-infections Surgical Site Complications
time frame: 4 weeks after cesarean delivery
description: Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.
arm group label: Chlorhexidine - Isopropyl alcohol
arm group type: Experimental
description: Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol
arm group label: Povidone-Iodine Scrub and Paint
arm group type: Experimental
description: Pre-operative skin preparation with Povidone-Iodine Scrub and Paint
intervention type: Drug
intervention name: Chlorhexidine - Isopropyl alcohol
description: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
arm group label: Chlorhexidine - Isopropyl alcohol
other name: Chlora-Prep
intervention type: Drug
intervention name: Povidone-Iodine Scrub and Paint
description: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
arm group label: Povidone-Iodine Scrub and Paint
other name: Betadine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brian B Mercer, MD
role: Principal Investigator
affiliation: MetroHealth Medical Center/Case Western Reserve
last name: Edward H Springel, MD
role: Principal Investigator
affiliation: MetroHealth Medical Center/Case Western Reserve
facility: 
country: United States
citation: Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
PMID: 20054046
responsible party type: Sponsor
mesh term: Surgical Wound Infection
mesh term: Chlorhexidine
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Lack of masking of clinical personnel to treatment assignment.
point of contact: 