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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT05625373
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Postoperative Complications

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vancomycin — DRUG
    The powder will be placed within the surgical wound prior to skin closure.

Study Details

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.

Key Dates

Start date
Oct 25, 2022
Status verified
Dec 2023
Primary completion
Apr 25, 2024
Completion
Aug 30, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Composite rate of postoperative complications [ Time Frame: Within 30 days after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women and Infants HospitalProvidenceRhode Island02905
Jessica DiSilvestro, MD
[email protected]
401-274-1100
Elizabeth Lokich, MD
[email protected]
401-274-1100
Elizabeth Lokich, MD (PRINCIPAL_INVESTIGATOR)

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