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

Обзор

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.

Подробное описание

The aim of the study is to investigate the impact of intrawound vancomycin powder on surgical site 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 inguinal lymph 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. The investigators will identify women who are planning to undergo inguinal lymph node dissection for vulvar cancer and after consented will be randomized to either receive intrawound vancomycin powder in the operating room or to not receive intrawound 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).

Patients will be followed post operatively at their standard postoperative visits typically at 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 assess recovery and complications. Outcomes will be collected until six weeks postoperatively. The study will be conducted at a single institution

Вмешательства

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

Первичные конечные точки

• Composite rate of postoperative complications [Срок оценки: Within 30 days after surgery]

Вторичные конечные точки (2)

• Antibiotic resistant infections [Срок оценки: Within 30 days after surgery]
• Allergic reactions [Срок оценки: Within 30 days after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Known allergy to vancomycin
• Known resistance to vancomycin

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Women and Infants Hospital — Providence

Публикации

• DiSilvestro JB, Zitek E, Robison K, Ebott J, Jansen C, Eurich K, Mathews C, DiSilvestro P, Oliver M, Stuckey A, Miller K, Lokich E. The effect of intrawound vancomycin powder on surgical site infection in inguinal lymph node dissection: a randomized controlled trial pilot study. Gynecol Oncol Rep. 2025 May 9;59:101765. doi: 10.1016/j.gore.2025.101765. eCollection 2025 Jun. PMID 40487852

Идентификаторы

NCT: NCT05625373 · 1895541

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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