Vancomycin for Surgical Site Infections

Recruiting in Palo Alto (17 mi)

Overseen byJessica DiSilvestro, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Women and Infants Hospital of Rhode Island

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of 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.

Research Team

Jessica DiSilvestro, MD

Principal Investigator

Women & Infants Hospital

Eligibility Criteria

This trial is for women who previously had a lymph node dissection over 30 days ago and are now undergoing inguinal lymph node dissection for vulvar dysplasia. It includes those having either sentinel lymph node biopsy or full lymphadenectomy. Women with known allergies to vancomycin or resistance to it cannot participate.

Inclusion Criteria

I am having surgery for abnormal cells on my vulva involving lymph nodes.

I had lymph node surgery over a month ago.

I am having lymph node surgery in my groin area.

Exclusion Criteria

Known allergy to vancomycin

My infection is resistant to vancomycin.

Treatment Details

Interventions

Vancomycin (Antibiotic)

Trial OverviewThe study tests if applying vancomycin powder during surgery can reduce postoperative complications in patients after inguinal lymph node dissection for vulvar cancer. Participants will be randomly assigned to receive either vancomycin or no treatment, and monitored for 30 days.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Vancomycin powderExperimental Treatment1 Intervention

Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient). After dissection and irrigation of the surgical bed, the operating room staff will open the medication vial and sterilely dispense the medication into a sterile container. The surgeon will place the medication powder into the irrigated and hemostatic surgical bed. The procedure will be repeated on the opposite side after dissection.

Group II: No vancomycin powderActive Control1 Intervention

Patient randomized to the no vancomycin arm will not receive the intraoperative antibiotic. Their surgery will follow standard protocol. No placebo will be utilized.