PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
Recruiting
New York Medical College
Phase 4
2020-07-15
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.
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