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NCT05625373
The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
Conditions: Postoperative Complications
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE2, PHASE3
Enrollment: 30
Sponsor: Women and Infants Hospital of Rhode Island
Location: United States
Summary
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
Inclusion Criteria:Women who are undergoing inguinal lymph node dissection for vulvar dysplasiaWomen with a prior lymph node dissection >30 days beforeWomen undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissectionExclusion Criteria:Known allergy to vancomycinKnown resistance to vancomycin
Source: ClinicalTrials.gov (NCT05625373). StuddyBuddy aggregates publicly available trial information.