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RecruitingAccepts healthy volunteersPhase 2/Phase 3

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

Women and Infants Hospital of Rhode Island · NCT05625373

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
30
US sites recruiting
1
Study start
October 25, 2022
Record last updated
December 5, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Vancomycin

Conditions: Postoperative Complications

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Women and Infants Hospital

    Providence, RI 02905

    Site contact: Jessica DiSilvestro, MD · 401-274-1100 · jdisilvestro@wihri.org

Study contacts (from the official record)

  • Jessica DiSilvestro, MD · 401-274-1100 · jdisilvestro@wihri.org
All healthy volunteers studies in Rhode Island →
The Effect of Intrawound Vancomycin Powder on Surgical Site… (NCT05625373) | Bored Studies