Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 and up Women only

Using vancomycin powder to prevent infections after inguinal lymph node dissection

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

Run by Women and Infants Hospital of Rhode Island · NCT05625373 · Data updated 2026-11-12

This study is testing if using vancomycin powder during surgery can help prevent infections and other complications for women having lymph node surgery for vulvar cancer.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment30 (estimated)
SponsorWomen and Infants Hospital of Rhode Island
Academic / other
Locations1 site (Providence, Rhode Island)
StatusRecruiting
StartedOctober 25, 2022
Main results expectedApril 25, 2024
Study endsAugust 30, 2024
Registry record updatedDecember 5, 2023
Trial IDNCT05625373 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women scheduled for inguinal lymph node dissection due to vulvar cancer or dysplasia.

Probably not a fit

Patients with known allergies to vancomycin or those with vancomycin resistance will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized control trial aims to evaluate the effectiveness of intrawound vancomycin powder in reducing postoperative complications in women undergoing inguinal lymph node dissection for vulvar cancer. Participants will be randomly assigned to receive either vancomycin powder or no treatment during surgery. The primary focus is on measuring the rate of postoperative complications, including surgical site infections and hospital readmissions, within 30 days post-surgery. Secondary objectives include monitoring for seroma or lymphocele development and documenting any adverse events related to the treatment.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections and improve recovery outcomes for patients undergoing this procedure.

How similar studies have gone: Previous studies have shown promising results with the use of intrawound antibiotics in reducing surgical site infections, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Known allergy to vancomycin
* Known resistance to vancomycin

Where it's running

  • Women and Infants Hospital
    Providence, Rhode Island, United States
    Recruiting

Study contacts

  • Principal investigator: Jessica DiSilvestro, MD — Women & Infants Hospital
  • Study coordinator: Jessica DiSilvestro, MD
  • Email: jdisilvestro@wihri.org
  • Phone: 401-274-1100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.