The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island

About this trial

The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery (compared to no vancomycin placement) with the goal of reducing postoperative complications in patients undergoing an inguinal lymph node dissection for vulvar cancer. The primary objective is to measure the composite rate of postoperative complications within 30 days of inguinal lymph node dissection in patients with vulvar cancer.

Eligibility criteria

Qualifiers

Women who are undergoing inguinal lymph node dissection for vulvar dysplasia

Women with a prior lymph node dissection >30 days before

Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection

Disqualifiers

Known allergy to vancomycin

Known resistance to vancomycin

Trial design

Treatments tested in this trial

  • Vancomycin

Treatment groups

30 Participants
are divided into 2 treatment groups