Status:
UNKNOWN
PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
Lead Sponsor:
New York Medical College
Conditions:
Post-Op Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 in...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Any female aged 18 years old and over
- Patient scheduled for elective subtotal (removal of uterus only with or without ovaries) or total hysterectomy (removal of uterus and cervix with or without ovaries) by any route of surgery. Procedures will include laparoscopic, robotic, open and vaginal approaches.
Exclusion
- Known hypersensitivity to metronidazole (oral or vaginal)
- Hysterectomy scheduled within 5 days of study enrollment (ie there will not be enough time to complete the study drug course)
- Suspected active bacterial vaginosis at time of consent
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04478617
Start Date
July 15 2020
End Date
May 1 2023
Last Update
May 17 2023
Active Locations (2)
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1
NYC Health + Hospitals/Metropolitan Hospital
New York, New York, United States, 10029
2
Westchester Medical Center/New York Medical College
Valhalla, New York, United States, 10595