The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
NCT ID: NCT05625373
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2022-10-25
2024-08-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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). 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.
Vancomycin
The powder will be placed within the surgical wound prior to skin closure.
No vancomycin powder
Patient randomized to the no vancomycin arm will not receive the intraoperative antibiotic. Their surgery will follow standard protocol. No placebo will be utilized.
No interventions assigned to this group
Interventions
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Vancomycin
The powder will be placed within the surgical wound prior to skin closure.
Eligibility Criteria
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Inclusion Criteria
* 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 resistance to vancomycin
18 Years
FEMALE
Yes
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Jessica DiSilvestro
Principle Investigator
Principal Investigators
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Jessica DiSilvestro, MD
Role: PRINCIPAL_INVESTIGATOR
Women & Infants Hospital
Locations
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Women and Infants Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica DiSilvestro, MD
Role: primary
Elizabeth Lokich, MD
Role: backup
References
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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.
Other Identifiers
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1895541
Identifier Type: -
Identifier Source: org_study_id