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Vancomycin for Surgical Site Infections
Phase 2 & 3
Recruiting
Led By Jessica DiSilvestro, MD
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women who are undergoing inguinal lymph node dissection for vulvar dysplasia
Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days after surgery
Awards & highlights
Study Summary
This trial will study if a common antibiotic can reduce post-op complications in patients with vulvar cancer having inguinal lymph node surgery.
Who is the study for?
This trial is for women who previously had a lymph node dissection over 30 days ago and are now undergoing inguinal lymph node dissection for vulvar dysplasia. It includes those having either sentinel lymph node biopsy or full lymphadenectomy. Women with known allergies to vancomycin or resistance to it cannot participate.Check my eligibility
What is being tested?
The study tests if applying vancomycin powder during surgery can reduce postoperative complications in patients after inguinal lymph node dissection for vulvar cancer. Participants will be randomly assigned to receive either vancomycin or no treatment, and monitored for 30 days.See study design
What are the potential side effects?
While the trial focuses on preventing infections, potential side effects of vancomycin may include allergic reactions, irritation at the surgical site, kidney problems, or hearing issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery for abnormal cells on my vulva involving lymph nodes.
Select...
I am having lymph node surgery in my groin area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite rate of postoperative complications
Secondary outcome measures
Allergic reactions
Antibiotic resistant infections
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vancomycin powderExperimental Treatment1 Intervention
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.
Group II: No vancomycin powderActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930
Find a Location
Who is running the clinical trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
108 Previous Clinical Trials
38,510 Total Patients Enrolled
Jessica DiSilvestro, MDPrincipal InvestigatorWomen & Infants Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for abnormal cells on my vulva involving lymph nodes.My infection is resistant to vancomycin.I had lymph node surgery over a month ago.I am having lymph node surgery in my groin area.
Research Study Groups:
This trial has the following groups:- Group 1: Vancomycin powder
- Group 2: No vancomycin powder
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research endeavor currently open?
"Affirmative. The clinical trial's post on clinicaltrials.gov indicates that it is currently searching for 30 participants from a single location, with the initial posting being 25th of October 2022 and an update as recent as 21st November 2022."
Answered by AI
How many participants is this clinical experiment currently accommodating?
"Affirmative. Clinicaltrials.gov details that this research project, which was created on October 25th 2022, is currently recruiting participants. Approximately 30 people are needed from 1 medical site to participate in this trial."
Answered by AI
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