The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Rhode Island
Women and Infants Hospital
RECRUITING
Providence
Contact Information
Primary
Jessica DiSilvestro, MD
jdisilvestro@wihri.org
401-274-1100
Time Frame
Start Date: 2022-10-25
Estimated Completion Date: 2024-08-30
Participants
Target number of participants: 30
Treatments
Experimental: Vancomycin powder
Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient). After dissection and irrigation of the surgical bed, the operating room staff will open the medication vial and sterilely dispense the medication into a sterile container. The surgeon will place the medication powder into the irrigated and hemostatic surgical bed. The procedure will be repeated on the opposite side after dissection.
No_intervention: No vancomycin powder
Patient randomized to the no vancomycin arm will not receive the intraoperative antibiotic. Their surgery will follow standard protocol. No placebo will be utilized.
Related Therapeutic Areas
Sponsors
Leads: Women and Infants Hospital of Rhode Island