The effect of intrawound vancomycin powder on surgical site infection in inguinal lymph node dissection: a randomized controlled trial pilot study.

BACKGROUND

Inguinal lymph node dissections are morbid surgeries with high rates of postoperative wound infections. The primary objective of this pilot study was to assess the feasibility of implementing a randomized controlled trial to assess the impact of intrawound vancomycin powder on postoperative complications after inguinal lymph node dissection in patients with vulvar cancer. Secondary objectives included 1) 30-day composite postoperative complication rate, and 2) adverse effects.

METHODS

This was a single-site, unblinded randomized controlled trial. Patients with vulvar cancer planning to undergo an inguinal lymph node dissection were randomized 1:1 to receive intrawound vancomycin powder at the time of surgery versus standard of care without vancomycin powder. Descriptive statistics and Chi-square were utilized.

RESULTS

Between October 2022 to May 2024, 31 patients met eligibility criteria and 30 patients enrolled (97 % recruitment rate). Three patients did not undergo surgery (90 % retention rate). All patients received their correctly assigned arm and all patients completed the postoperative follow-up (100 % adherence rate).One patient in the vancomycin group had a composite postoperative complication (hematoma), while three patients in the control arm had a complication (three inguinal surgical site infections) [8 % vs. 21 %, p = 0.32]. There were no postoperative infections identified in the patients who received intrawound vancomycin powder. No adverse events occurred with the application of vancomycin.

CONCLUSION

This pilot study showed that this was a feasible trial with high recruitment, retention and adherence rates. The data supports proceeding with a larger trial to further elucidate the impact of this low-cost intervention.Trial Registration: ClinicalTrials.gov Identifier: NCT05625373.