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

The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
Recruiting
18 years or above
All
Phase 2/3
30 participants needed
3 Locations

Brief description of study

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.

Detailed description of study

The aim of the study is to investigate the impact of intrawound vancomycin powder on surgicalite infections. The primary objective is to measure the composite rate of postoperative complications, including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days of inguinalymph node dissection in women with vulvar cancer.
Secondary objectives include assessing the rate of seroma or lymphocele development within 30 days of surgery. Adverse events including allergic reactions (systemic or local hypersensitivity reactions) and antibiotic resistant infections (based on wound cultures) will be described.
The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery. We will identify women who are planning to undergo inguinal lymph node dissection for vulvar cancer and after consented will bendomized to either receive intrawound vancomycin powder in the operating room or to notceive intrawound vancomycin powder. Women randomized to receive vancomycin powder willceive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient).
Patients will be followed post operatively at their standard postoperative visits typicallyt 1-3 week intervals until adequate healing of their incisions. An electronic questionnaire will be administered to all patients at the postoperative visits between 3-6 weeks to assesscovery and complications. Outcomes will be collected until six weeks postoperatively. Thetudy will be conducted at a single institution

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Postoperative Complications
  • Age: 18 years or above
  • Gender: All

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 aunilateral or bilateral groin dissection
Exclusion Criteria:
  • Known allergy to vancomycin
  • Known resistance to vancomycin

Updated on 03 Dec 2024. Study ID: 1895541

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