PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and...

Area of Science:

• Gynecology
• Surgical Infections
• Pharmacology

Background:

• Surgical site infections (SSIs) and postoperative complications are significant concerns following hysterectomy.
• Vaginal antibiotics are sometimes used to prevent infections, but evidence for their efficacy is limited.

Purpose of the Study:

• To evaluate the effectiveness of a 5-day course of vaginal metronidazole administered before hysterectomy in reducing postoperative infections and patient issues.
• To assess the impact of this intervention on patient-reported outcomes and documented infections.

Main Methods:

• A randomized controlled trial was conducted comparing vaginal metronidazole (5 days pre-surgery) to no intervention in patients scheduled for hysterectomy.
• Sample size was calculated for 80% power to detect a 20% difference in infection/issue rates.
• 133 patients (68 metronidazole, 65 control) were included; outcomes were assessed 4-8 weeks post-surgery.

Main Results:

• No significant difference was observed in the composite rate of patient-reported issues and/or documented postoperative infection between the metronidazole and control groups (39.8% vs. 36.9%, p=0.50).
• Individual analysis of patient-reported issues (38.3%) and documented infections (18.8%) also showed no significant group differences.
• A per-protocol analysis, considering 73.5% compliance in the intervention arm, yielded similar non-significant results.

Conclusions:

• The study found insufficient evidence to support the routine use of preoperative vaginal metronidazole for preventing surgical site infections or postoperative complications in hysterectomy patients.
• Current evidence does not demonstrate a significant benefit of this prophylactic regimen.