Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05625373

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

Led by Women and Infants Hospital of Rhode Island · Updated on 2023-12-05

30

Participants Needed

1

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women who are undergoing inguinal lymph node dissection for vulvar dysplasia
  • Women with a prior lymph node dissection more than 30 days before
  • Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection
Not Eligible

You will not qualify if you...

  • Known allergy to vancomycin
  • Known resistance to vancomycin

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Women and Infants Hospital

Providence, Rhode Island, United States, 02905

Actively Recruiting

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Research Team

J

Jessica DiSilvestro, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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