The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
Recruiting
Phase 2
Phase 3
Interventional Study
Postoperative Complications
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 30 (estimated)
- Sponsor
- Women and Infants Hospital of Rhode Island · Other
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About 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 3…
Trial Locations
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Eligibility 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 Crit…
Contacts