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Antibiotic

Vancomycin Powder for Fractures (POWDER Trial)

Phase 4

Recruiting

Led By Robert A De Lorenzo, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.

Adult 18 years of age or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within one year of injury date

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial found that vancomycin powder reduces infection-related complications when applied to open fractures in the emergency department.

Who is the study for?

Adults over 18 with open fractures of certain bones who can consent to the study within 24 hours of injury. Excluded are those treated with high-potency antibiotics, allergic to vancomycin, pregnant women, prisoners, and subjects already operated on for the fracture elsewhere.

What is being tested?

The trial is testing if applying vancomycin powder directly into open fractures in the emergency room can reduce infection-related complications compared to not using it or standard treatments.

What are the potential side effects?

Potential side effects may include allergic reactions specific to vancomycin such as skin rashes or more severe responses. However, since it's applied topically in a wound rather than taken systemically, some common systemic side effects might be less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an open fracture in one of my major bones.

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I am 18 years old or older.

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My injury occurred less than 24 hours ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one year of injury date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within one year of injury date

This trial's timeline: 3 weeks for screening, Varies for treatment, and within one year of injury date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Deep-space infection rate at prophylaxis site

Secondary study objectives

Death rate

Readmission rate for open fracture infection

Superficial infection rate requiring post-operative medical intervention

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.

Group II: Observational ArmActive Control1 Intervention

Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.

Group III: Control ArmActive Control1 Intervention

Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

2020

Completed Phase 4

~7920

0 / 3Eligibility criteria met