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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Postoperative Complications

In brief

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.

Key facts

Study ID

NCT05625373

Run by

Women and Infants Hospital of Rhode Island

People needed

30

Starts

2022-10-25

Expected to finish

2024-08-30

Last updated by the study team

2023-12-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Known allergy to vancomycin
• Known resistance to vancomycin

Where it is running

• Women and Infants Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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