Clinical trial NCT05625373: The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
Official title: The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Postoperative Complications
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 unblinded to either receive vancomycin powder in the operating room or no vancomycin powder (no placebo utilized).
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: Composite rate of postoperative complications
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Antibiotic resistant infections
timeFrame: Within 30 days after surgery
measure: Allergic reactions
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Jessica DiSilvestro, MD
role: PRINCIPAL_INVESTIGATOR
References: