Vancomycin powder for Postoperative Complications

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Postoperative ComplicationsVancomycin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Postoperative Complications

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Within 30 days after surgery

Day 30
Allergic reactions
Antibiotic resistant infections
Composite rate of postoperative complications

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

No vancomycin powder
1 of 2
Vancomycin powder
1 of 2

Active Control

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Vancomycin powder · No Placebo Group · Phase 2 & 3

Vancomycin powder
Drug
Experimental Group · 1 Intervention: Vancomycin · Intervention Types: Drug
No vancomycin powderNoIntervention Group · 1 Intervention: No vancomycin powder · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 30 days after surgery

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
100 Previous Clinical Trials
36,724 Total Patients Enrolled
Jessica DiSilvestro, MDPrincipal InvestigatorWomen & Infants Hospital

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

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