PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?

Status unconfirmed · Phase 4

Conditions studied: Post-Op Infection

In brief

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.

Key facts

Study ID

NCT04478617

Run by

New York Medical College

People needed

136

Starts

2020-07-15

Expected to finish

2023-05-01

Last updated by the study team

2023-05-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• NYC Health + Hospitals/Metropolitan Hospital — New York, New York, United States
• Westchester Medical Center/New York Medical College — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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