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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625373
• Other study ID #: 1895541
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: December 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: Jessica DiSilvestro, MD
• Phone: 401-274-1100
• Email: jdisilvestro[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite rate of postoperative complications	Rate of composite postoperative complications including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days	Within 30 days after surgery
Secondary	Antibiotic resistant infections	Rate of antibiotic resistant infections based on wound cultures of a postoperative infection	Within 30 days after surgery
Secondary	Allergic reactions	Rate of systemic or local hypersensitivity reactions of the inguinal incision	Within 30 days after surgery