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

NCT05625373 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 1895541
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Antibiotic resistant infections

  Within 30 days after surgery

• Allergic reactions

  Within 30 days after surgery

Study Arms (2)

Vancomycin powder

EXPERIMENTAL

Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient). After dissection and irrigation of the surgical bed, the operating room staff will open the medication vial and sterilely dispense the medication into a sterile container. The surgeon will place the medication powder into the irrigated and hemostatic surgical bed. The procedure will be repeated on the opposite side after dissection.

Drug: Vancomycin

No vancomycin powder

NO INTERVENTION

Patient randomized to the no vancomycin arm will not receive the intraoperative antibiotic. Their surgery will follow standard protocol. No placebo will be utilized.

Interventions

Vancomycin DRUG

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

Vancomycin powder

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to vancomycin
• Known resistance to vancomycin

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jessica DiSilvestro, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica DiSilvestro, MD

CONTACT

401-274-1100; jdisilvestro@wihri.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized 1:1 unblinded to either receive vancomycin powder in the operating room or no vancomycin powder (no placebo utilized).

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: October 25, 2022
• Primary Completion: April 25, 2024
• Study Completion: August 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)