<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/NCT04478617</url>
  </required_header>
  <id_info>
    <org_study_id>14176</org_study_id>
    <nct_id>NCT04478617</nct_id>
  </id_info>
  <brief_title>PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?</brief_title>
  <acronym>PREVENT</acronym>
  <official_title>PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Medical College</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite use of intravenous antibiotic prophylaxis, pelvic infection including vaginal and&#xD;
      urinary complaints and infections are still noted after hysterectomy. For gynecologic surgery&#xD;
      the burden of infection is not only from the skin but from the vagina and urinary tract.&#xD;
      Hysterectomy involves a communication via the cervical or vaginal canal directly with the&#xD;
      pelvis and thus can lead to a potentially increased risk of infection from both aerobic and&#xD;
      anaerobic organisms. Vaginal metronidazole is a standard of care antibiotic for vaginal&#xD;
      infections including bacterial vaginosis. Based upon small studies in the peri-operative&#xD;
      setting, vaginal metronidazole may provide a benefit in decreasing surgical site infections&#xD;
      and urinary infections in conjunction with standard infection prevention protocols.&#xD;
&#xD;
      This study is for women undergoing elective subtotal or total hysterectomy by any route of&#xD;
      surgery. The main objective of this study is to evaluate if metronidazole inserted per vagina&#xD;
      daily for 5 days before elective hysterectomy decreases patient complaints of potential&#xD;
      infection or documented post-operative infection.&#xD;
&#xD;
      Subjects will be randomized to an intervention or control group. For subjects in the&#xD;
      intervention group, vaginal metronidazole 0.75% (MetroGel or Vandazole) will be prescribed&#xD;
      and inserted per vagina days 1 through 5 prior to date of surgery. The control group will not&#xD;
      receive a metronidazole prescription.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard of care surgical site infection (SSI) antibiotic prophylaxis for elective&#xD;
      hysterectomy is a single intravenous antibiotic. Despite use of intravenous antibiotic&#xD;
      prophylaxis, pelvic infection including vaginal and urinary complaints and infections are&#xD;
      still often noted after hysterectomy. For gynecologic surgery the burden of infection is not&#xD;
      only from the skin but from the vagina and urinary tract. Hysterectomy involves a&#xD;
      communication via the cervical or vaginal canal directly with the pelvis and thus can lead to&#xD;
      a potentially increased risk of infection from both aerobic and anaerobic organisms.&#xD;
&#xD;
      There has been scant retrospective data examining the use of metronidazole as an adjunct to&#xD;
      standard antibiotic prophylaxis for hysterectomy. A few previous studies have examined the&#xD;
      use of vaginal metronidazole in patients who had a documented overgrowth of normal bacterial&#xD;
      flora (e.g. diagnosed with bacterial vaginosis) prior to hysterectomy in pre-menopausal women&#xD;
      only and found a significant difference in prevention of infections.&#xD;
&#xD;
      Vaginal metronidazole is a standard of care antibiotic for vaginal infections including&#xD;
      bacterial vaginosis. Based upon small studies in the peri-operative setting, vaginal&#xD;
      metronidazole may provide a benefit in decreasing surgical site infections and urinary&#xD;
      infections in conjunction with standard infection prevention protocols.&#xD;
&#xD;
      For post-operative patients, the symptoms of vaginal discharge, dysuria, pelvic pain and&#xD;
      wound erythema/induration/drainage is not only distressing for the patient but leads to&#xD;
      additional phone calls, patient visits, laboratory and radiology evaluation and possibly&#xD;
      additional pain, and antibiotic prescriptions. This increased use of health care services can&#xD;
      cause a burden to our health care system and diminish overall patient satisfaction.&#xD;
      Therefore, if additional prophylaxis can also prevent patient reported symptoms of&#xD;
      post-operative infection, the intervention may be of value.&#xD;
&#xD;
      The objective of this study is to investigate if metronidazole inserted per vagina daily for&#xD;
      5 days before elective hysterectomy decreases patient complaints of potential infection or&#xD;
      documented post-operative infection.&#xD;
&#xD;
      Subjects randomized to the intervention are required to pick up the antibiotic at their own&#xD;
      pharmacy. They must then insert the antibiotic per vagina once daily on days 1-5 (day 5 being&#xD;
      the day before their scheduled operation).&#xD;
&#xD;
      There are no study related visits, imaging, or testing required above standard peri-operative&#xD;
      procedures as per their gynecologic surgeon. Subjects randomized to the control group (no&#xD;
      antibiotic) are followed for data collection only. Subjects in both groups will have a&#xD;
      routine hospital stay for surgery and their routine follow up for post-operative care as per&#xD;
      the standard practice of the gynecologic surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite variable of patient reported symptom or documented post-operative infection by the 4 to 8-week post-operative visit(s).</measure>
    <time_frame>8 weeks following surgery.</time_frame>
    <description>Patient reported symptom= patient report of dysuria, vaginal discharge with or without pelvic pain, fever, wound redness/erythema/drainage documented in the post-operative visit or complaint that generates an additional post-operative visit for evaluation.&#xD;
Documented post-operative infection= Urinary tract infection either empirically treated with antibiotics or culture proven infection, vaginal discharge with or without pelvic pain or that warrants treatment with antibiotics, vaginal cuff cellulitis or vaginitis, pelvic abscess (confirmed by pelvic ultrasound or CT scan with or without vaginal cultures) that results in antibiotic use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit.</measure>
    <time_frame>8 weeks following surgery.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Post-Op Infection</condition>
  <arm_group>
    <arm_group_label>Metronidazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole Vaginal</intervention_name>
    <description>Vaginal metronidazole 0.75% (MetroGel or Vandazole) will be inserted per vagina days 1 through 5 prior to date of surgery.</description>
    <arm_group_label>Metronidazole</arm_group_label>
    <other_name>MetroGel</other_name>
    <other_name>Vandazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any female aged 18 years old and over&#xD;
&#xD;
          -  Patient scheduled for elective subtotal (removal of uterus only with or without&#xD;
             ovaries) or total hysterectomy (removal of uterus and cervix with or without ovaries)&#xD;
             by any route of surgery. Procedures will include laparoscopic, robotic, open and&#xD;
             vaginal approaches.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to metronidazole (oral or vaginal)&#xD;
&#xD;
          -  Hysterectomy scheduled within 5 days of study enrollment (ie there will not be enough&#xD;
             time to complete the study drug course)&#xD;
&#xD;
          -  Suspected active bacterial vaginosis at time of consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NYC Health + Hospitals/Metropolitan Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center/New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hysterectomy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04478617
org study id: 14176
nct id: NCT04478617
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Despite use of intravenous antibiotic prophylaxis, pelvic infection including vaginal and
      urinary complaints and infections are still noted after hysterectomy. For gynecologic surgery
      the burden of infection is not only from the skin but from the vagina and urinary tract.
      Hysterectomy involves a communication via the cervical or vaginal canal directly with the
      pelvis and thus can lead to a potentially increased risk of infection from both aerobic and
      anaerobic organisms. Vaginal metronidazole is a standard of care antibiotic for vaginal
      infections including bacterial vaginosis. Based upon small studies in the peri-operative
      setting, vaginal metronidazole may provide a benefit in decreasing surgical site infections
      and urinary infections in conjunction with standard infection prevention protocols.

      This study is for women undergoing elective subtotal or total hysterectomy by any route of
      surgery. The main objective of this study is to evaluate if metronidazole inserted per vagina
      daily for 5 days before elective hysterectomy decreases patient complaints of potential
      infection or documented post-operative infection.

      Subjects will be randomized to an intervention or control group. For subjects in the
      intervention group, vaginal metronidazole 0.75% (MetroGel or Vandazole) will be prescribed
      and inserted per vagina days 1 through 5 prior to date of surgery. The control group will not
      receive a metronidazole prescription.
Standard of care surgical site infection (SSI) antibiotic prophylaxis for elective
      hysterectomy is a single intravenous antibiotic. Despite use of intravenous antibiotic
      prophylaxis, pelvic infection including vaginal and urinary complaints and infections are
      still often noted after hysterectomy. For gynecologic surgery the burden of infection is not
      only from the skin but from the vagina and urinary tract. Hysterectomy involves a
      communication via the cervical or vaginal canal directly with the pelvis and thus can lead to
      a potentially increased risk of infection from both aerobic and anaerobic organisms.

      There has been scant retrospective data examining the use of metronidazole as an adjunct to
      standard antibiotic prophylaxis for hysterectomy. A few previous studies have examined the
      use of vaginal metronidazole in patients who had a documented overgrowth of normal bacterial
      flora (e.g. diagnosed with bacterial vaginosis) prior to hysterectomy in pre-menopausal women
      only and found a significant difference in prevention of infections.

      Vaginal metronidazole is a standard of care antibiotic for vaginal infections including
      bacterial vaginosis. Based upon small studies in the peri-operative setting, vaginal
      metronidazole may provide a benefit in decreasing surgical site infections and urinary
      infections in conjunction with standard infection prevention protocols.

      For post-operative patients, the symptoms of vaginal discharge, dysuria, pelvic pain and
      wound erythema/induration/drainage is not only distressing for the patient but leads to
      additional phone calls, patient visits, laboratory and radiology evaluation and possibly
      additional pain, and antibiotic prescriptions. This increased use of health care services can
      cause a burden to our health care system and diminish overall patient satisfaction.
      Therefore, if additional prophylaxis can also prevent patient reported symptoms of
      post-operative infection, the intervention may be of value.

      The objective of this study is to investigate if metronidazole inserted per vagina daily for
      5 days before elective hysterectomy decreases patient complaints of potential infection or
      documented post-operative infection.

      Subjects randomized to the intervention are required to pick up the antibiotic at their own
      pharmacy. They must then insert the antibiotic per vagina once daily on days 1-5 (day 5 being
      the day before their scheduled operation).

      There are no study related visits, imaging, or testing required above standard peri-operative
      procedures as per their gynecologic surgeon. Subjects randomized to the control group (no
      antibiotic) are followed for data collection only. Subjects in both groups will have a
      routine hospital stay for surgery and their routine follow up for post-operative care as per
      the standard practice of the gynecologic surgeon.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Composite variable of patient reported symptom or documented post-operative infection by the 4 to 8-week post-operative visit(s).
time frame: 8 weeks following surgery.
description: Patient reported symptom= patient report of dysuria, vaginal discharge with or without pelvic pain, fever, wound redness/erythema/drainage documented in the post-operative visit or complaint that generates an additional post-operative visit for evaluation.
Documented post-operative infection= Urinary tract infection either empirically treated with antibiotics or culture proven infection, vaginal discharge with or without pelvic pain or that warrants treatment with antibiotics, vaginal cuff cellulitis or vaginitis, pelvic abscess (confirmed by pelvic ultrasound or CT scan with or without vaginal cultures) that results in antibiotic use.
measure: Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit.
time frame: 8 weeks following surgery.
arm group label: Metronidazole
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Drug
intervention name: Metronidazole Vaginal
description: Vaginal metronidazole 0.75% (MetroGel or Vandazole) will be inserted per vagina days 1 through 5 prior to date of surgery.
arm group label: Metronidazole
other name: MetroGel
other name: Vandazole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Metronidazole