Antibiotic Powder for Open Fractures

Phase < 1

Waitlist Available

Led By Justin Haller, M.D.

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post-operative

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effect of a new treatment for open fracture healing, comparing it to the current standard of care.

Who is the study for?

This trial is for patients with open fractures of specific bones (like the heel, shinbone, or thigh bone) and a moderate to severe injury grade. They must be able to give consent in the emergency department. It's not for those allergic to vancomycin or tobramycin, have advanced kidney disease, are pregnant, or refuse participation.

What is being tested?

The study aims to compare infection rates between two groups: one receiving standard care antibiotics and another getting a combination of vancomycin and tobramycin powder. Each group will have 25 patients randomly assigned and followed up for six months post-surgery.

What are the potential side effects?

Potential side effects may include allergic reactions to antibiotics used, local wound irritation at the site where medications are applied directly into the fracture area during surgery, and possible impact on kidney function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post-operative for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent (%) negative deep tissue infections.

Percent (%) positive deep tissue infections.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vancomycin and TobramycinExperimental Treatment1 Intervention

One-time dosage of topical vancomycin (1 gram) and tobramycin (1.2 grams) powder.

Group II: Standard of care prophylactic antibioticsActive Control1 Intervention

Standard irrigation and IV, cephalosporin, 2-grams, intravenous (IV), * or standard irrigation and IV, clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV) for patients with cephalosporin allergies.

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