<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/NCT03305159</url>
  </required_header>
  <id_info>
    <org_study_id>STU00204759</org_study_id>
    <nct_id>NCT03305159</nct_id>
  </id_info>
  <brief_title>Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution</brief_title>
  <official_title>Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4%&#xD;
      isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical&#xD;
      preparations of the vagina. Patients will be randomized to either control (povidone iodine)&#xD;
      or experimental (chlorhexidine gluconate), and then be given a short survey prior to and&#xD;
      immediately after surgery, and again 24-48 hours via phone asking them about the presence and&#xD;
      severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or&#xD;
      burning with urination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical site antisepsis is critical in preventing surgical site infections. Although&#xD;
      chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site&#xD;
      antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical&#xD;
      preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for&#xD;
      preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is&#xD;
      implicated in a greater risk of irritation. Yet, there has been no randomized study to&#xD;
      illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate&#xD;
      versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control&#xD;
      trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using&#xD;
      patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to&#xD;
      either control or experimental, and then be given a short survey prior to and immediately&#xD;
      after surgery, and again 24-48 hours via phone asking them about the presence and severity of&#xD;
      vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with&#xD;
      urination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 15, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <phase>Phase 4</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>Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)</measure>
    <time_frame>Day of surgery to 24-48 hours after surgery</time_frame>
    <description>To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Surgical Preparation of the Vagina</condition>
  <arm_group>
    <arm_group_label>Control (Povidone Iodine)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients to receive povidone iodine for the surgical preparation of the vagina.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention (4% Chlorhexidine gluconate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-Iodine</intervention_name>
    <description>Patients will receive povidone iodine for the surgical preparation of the vagina.</description>
    <arm_group_label>Control (Povidone Iodine)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4% Chlorhexidine Gluconate</intervention_name>
    <description>Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.</description>
    <arm_group_label>Intervention (4% Chlorhexidine gluconate)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Undergoing hysteroscopy&#xD;
&#xD;
          2. Gynecologic dilation &amp; curettage&#xD;
&#xD;
          3. Endometrial ablation&#xD;
&#xD;
          4. Essure without concomitant laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant&#xD;
&#xD;
          2. Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or&#xD;
             anaphylaxis to chlorhexidine gluconate or povidone iodine.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdy Milad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prentice Women's Hospital - Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/23963423</url>
    <description>ACOG Solutions for the Surgical Preparation of the Vagina</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <results_first_submitted>April 11, 2019</results_first_submitted>
  <results_first_submitted_qc>June 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 27, 2019</results_first_posted>
  <last_update_submitted>June 9, 2019</last_update_submitted>
  <last_update_submitted_qc>June 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Magdy Milad, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>May 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03305159/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control (Povidone Iodine)</title>
          <description>Patients to receive povidone iodine for the surgical preparation of the vagina.&#xD;
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.</description>
        </group>
        <group group_id="P2">
          <title>Intervention (4% Chlorhexidine Gluconate)</title>
          <description>Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.&#xD;
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control (Povidone Iodine)</title>
          <description>Patients to receive povidone iodine for the surgical preparation of the vagina.&#xD;
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.</description>
        </group>
        <group group_id="B2">
          <title>Intervention (4% Chlorhexidine Gluconate)</title>
          <description>Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.&#xD;
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.</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="63"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="59"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </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="46" spread="10"/>
                    <measurement group_id="B2" value="44" spread="9"/>
                    <measurement group_id="B3" value="45" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="123"/>
                  </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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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="63"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)</title>
        <description>To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.</description>
        <time_frame>Day of surgery to 24-48 hours after surgery</time_frame>
        <population>Number of participants in control and active groups</population>
        <group_list>
          <group group_id="O1">
            <title>Control (Povidone Iodine)</title>
            <description>Patients to receive povidone iodine for the surgical preparation of the vagina.&#xD;
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.</description>
          </group>
          <group group_id="O2">
            <title>Intervention (4% Chlorhexidine Gluconate)</title>
            <description>Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.&#xD;
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)</title>
          <description>To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.</description>
          <population>Number of participants in control and active groups</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="63"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vaginal dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal burning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unusual vaginal discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain of burning with urination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal itchiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data were collected for each patient immediately postoperatively to 24-48 hours postoperatively.</time_frame>
      <desc>The survey of vaginal &amp; urinary symptoms used in this study was designed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) created by the NIH &amp; NCI 7. The language &amp; format of the PTO-CTCAE questions have been cognitively tested. Questions on vaginal burning and itching were investigator-developed items using similar language as the PRO-CTCAE, since these adverse events were not contained in the PRO-CTCAE item library.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control (Povidone Iodine)</title>
          <description>Patients to receive povidone iodine for the surgical preparation of the vagina.&#xD;
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.</description>
        </group>
        <group group_id="E2">
          <title>Intervention (4% Chlorhexidine Gluconate)</title>
          <description>Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.&#xD;
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.</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="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Severe Swelling</sub_title>
                <description>Genitourinary - One patient in the chlorhexidine group reported severe vulvar swelling that resolved within 24-48 hours after exposure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Single-blinded design. Present study included participants undergoing hysteroscopic procedures these procedures themselves may certainly influence postoperative irritative symptoms. Loss of follow-up both immediately and 24-48 hours postoperative.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Supriya Rastogi</name_or_title>
      <organization>Northwestern University Feinberg School of Medicine</organization>
      <phone>supriya.rastogi@northwestern.e</phone>
      <email>supriya.rastogi@northwestern.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/NCT03305159
org study id: STU00204759
nct id: NCT03305159
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4%
      isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical
      preparations of the vagina. Patients will be randomized to either control (povidone iodine)
      or experimental (chlorhexidine gluconate), and then be given a short survey prior to and
      immediately after surgery, and again 24-48 hours via phone asking them about the presence and
      severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or
      burning with urination.
Surgical site antisepsis is critical in preventing surgical site infections. Although
      chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site
      antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical
      preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for
      preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is
      implicated in a greater risk of irritation. Yet, there has been no randomized study to
      illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate
      versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control
      trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using
      patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to
      either control or experimental, and then be given a short survey prior to and immediately
      after surgery, and again 24-48 hours via phone asking them about the presence and severity of
      vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with
      urination.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
primary purpose: Other
masking: Single (Participant)
masking description: Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
measure: Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
time frame: Day of surgery to 24-48 hours after surgery
description: To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.
arm group label: Control (Povidone Iodine)
arm group type: Active Comparator
description: Patients to receive povidone iodine for the surgical preparation of the vagina.
arm group label: Intervention (4% Chlorhexidine gluconate)
arm group type: Experimental
description: Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
intervention type: Drug
intervention name: Povidone-Iodine
description: Patients will receive povidone iodine for the surgical preparation of the vagina.
arm group label: Control (Povidone Iodine)
intervention type: Drug
intervention name: 4% Chlorhexidine Gluconate
description: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
arm group label: Intervention (4% Chlorhexidine gluconate)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Magdy Milad, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/23963423
description: ACOG Solutions for the Surgical Preparation of the Vagina
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Magdy Milad, MD
investigator title: Principal Investigator
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Single-blinded design. Present study included participants undergoing hysteroscopic procedures these procedures themselves may certainly influence postoperative irritative symptoms. Loss of follow-up both immediately and 24-48 hours postoperative.
point of contact: 