Vancomycin Powder for Open Fractures

KD
Overseen ByKristen De Wilde MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Atlantic Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

To evaluate the feasibility, safety, and potential efficacy of applying vancomycin powder locally to open fractures in the emergency department prior to definitive surgical intervention.

Are You a Good Fit for This Trial?

This trial is for people who come to the emergency department with an open bone fracture. It does not specify detailed inclusion or exclusion criteria, but participants must have a broken bone where the skin is also broken.

Inclusion Criteria

I am 18 or older and have an open bone fracture.

Exclusion Criteria

Known allergy to vancomycin
Pregnancy
Currently breastfeeding
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What Are the Treatments Tested in This Trial?

Interventions

  • Vancomycin Powder

Trial Overview

The study compares standard care for open fractures with and without adding vancomycin powder directly to the wound in the emergency room before surgery, to see if this extra step helps prevent infection.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Emergency Department Vancomycin PowderExperimental Treatment1 Intervention
Group II: Standard Open Fracture CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials
58
Recruited
9,400+