Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Major Extremity Trauma Research Consortium

Criteria

Inclusion Criteria:

1. Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection:

1. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.

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

3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds.

2. Patients ages 18 through 80 years.

Exclusion Criteria:

1. Study injury is already infected at time of study enrollment.

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

3. The patient never receives study fixation.

4. Massive myonecrosis from ipsilateral leg compartment syndrome.

5. Currently pregnant.

6. Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information).

7. Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).

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