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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Status | Recruiting |
| Started | October 25, 2022 |
| Main results expected | April 25, 2024 |
| Study ends | August 30, 2024 |
| Registry record updated | December 5, 2023 |
| Trial ID | NCT05625373 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.