RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-25
Study Completion:2024-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05625373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women who are undergoing inguinal lymph node dissection for vulvar dysplasia
  2. * Women with a prior lymph node dissection \>30 days before
  3. * Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection
  1. * Known allergy to vancomycin
  2. * Known resistance to vancomycin

Contacts and Locations

Study Contact

Jessica DiSilvestro, MD
CONTACT
401-274-1100
jdisilvestro@wihri.org

Principal Investigator

Jessica DiSilvestro, MD
PRINCIPAL_INVESTIGATOR
Women & Infants Hospital

Study Locations (Sites)

Women and Infants Hospital
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: Women and Infants Hospital of Rhode Island

  • Jessica DiSilvestro, MD, PRINCIPAL_INVESTIGATOR, Women & Infants Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-25
Study Completion Date2024-08-30

Study Record Updates

Study Start Date2022-10-25
Study Completion Date2024-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Postoperative Complications