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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Vancomycin
DrugThe powder will be placed within the surgical wound prior to skin closure.
Treatment groups
Trial outcomes
Primary outcomes
Composite rate of postoperative complications
Rate of composite postoperative complications including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days
Secondary outcomes
Antibiotic resistant infections
Rate of antibiotic resistant infections based on wound cultures of a postoperative infection
Allergic reactions
Rate of systemic or local hypersensitivity reactions of the inguinal incision
Sponsors and contacts
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