RecruitingPhase 2Phase 3NCT05625373

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


Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

30 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • Known allergy to vancomycin
  • Known resistance to vancomycin

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Interventions

DRUGVancomycin

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


Locations(1)

Women and Infants Hospital

Providence, Rhode Island, United States

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NCT05625373


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