← Back to Search

Antibiotic

Topical Antibiotics for Surgical Site Infection

Phase 3

Recruiting

Led By Robert V O'Toole, MD, MS

Research Sponsored by Major Extremity Trauma Research Consortium

Eligibility Criteria Checklist

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

Must have

Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.

Patients ages 18 through 80 years.

Must not have

Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.

Definitive fixation of the study injury prior to enrollment in the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 182 days of definitive fracture fixation surgery

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a combination of Vancomycin and Tobramycin powders is better than just Vancomycin powder at reducing post-fixation infections of tibial plateau and tibial pilon fractures.

Who is the study for?

Adults aged 18-80 with high-risk tibial fractures initially treated with external fixation, who are now receiving plate and screw fixation. Ideal candidates have no severe allergies to Vancomycin or Tobramycin, are not pregnant, and can commit to follow-up appointments.

What is being tested?

The TOBRA study is testing if a combination of Vancomycin and Tobramycin powders reduces infection rates post-surgery better than just Vancomycin powder in patients with certain high-risk leg fractures.

What are the potential side effects?

Possible side effects include allergic reactions to the antibiotics used (Vancomycin or Tobramycin), which could manifest as skin rashes, difficulty breathing, or other hypersensitivity responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have an open fracture type I, II, or IIIA.

Select...

I am between 18 and 80 years old.

Select...

I have a broken shinbone with swelling and had surgery to relieve pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to Tobramycin or similar antibiotics.

Select...

My injury has been surgically treated before joining the study.

Select...

I have severe muscle damage in my leg due to increased pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 182 days of definitive fracture fixation surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 182 days of definitive fracture fixation surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 182 days of definitive fracture fixation surgery 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 Surgical Site Infection (SSI)

Secondary study objectives

Antibiotic resistance

Sensitivity analyses

Awards & Highlights

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

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.

Group II: ControlActive Control1 Intervention

Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treatment group

2010

Completed Phase 4

~740

0 / 6Eligibility criteria met