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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Known allergy to vancomycin

Known resistance to vancomycin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vancomycin

    Drug

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Vancomycin powderExperimental treatment 1 intervention
Group B: No vancomycin powderNo intervention 0 interventions

Trial outcomes

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

Time frame
Within 30 days after surgery

Secondary outcomes

1

Antibiotic resistant infections

Rate of antibiotic resistant infections based on wound cultures of a postoperative infection

Time frame
Within 30 days after surgery
2

Allergic reactions

Rate of systemic or local hypersensitivity reactions of the inguinal incision

Time frame
Within 30 days after surgery

Other outcomes

Sponsors and contacts

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