Recruiting
Phase 2
Phase 3

Vancomycin Powder

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT05625373

Conditions

Postoperative Complications

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vancomycin

Study Details

Brief 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.

Conditions

Postoperative Complications

Study ID

NCT05625373

Start date

Oct 25, 2022

Status verified date

Dec, 2023

Completion date

Aug 30, 2024

Anticipated

Primary completion date

Apr 25, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Criteria:

  • Known allergy to vancomycin
  • Known resistance to vancomycin

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Vancomycin

The powder will be placed within the surgical wound prior to skin closure.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jessica DiSilvestro, MD

401-274-1100jdisilvestro@wihri.org

Locations

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Jessica DiSilvestro, MD

401-274-1100jdisilvestro@wihri.org

Elizabeth Lokich, MD

401-274-1100elokich@wihri.org

Principal Investigator:

Elizabeth Lokich, MD

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Dec 5, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2023-12-05.