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

StatusRecruiting
PhasePhase 2/3
Started
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Record status
This record was last updated December 5, 2023 (before its estimated April 25, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Oct 25, 2023 to Apr 25, 2024
    • Study completion date: Jun 30, 2024 to Aug 30, 2024
    v3
  2. Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 1 word
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05625373
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)		 Postoperative Complications
Related terms Postoperative Complications
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov