TOBRA

Study Contact:

Dayna Sawyer

Work: 434-243-0246

Cell: 217-853-5342

IRB-HSR 210401

Clinic Visit Registration: 210401- Weiss

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:

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

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

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

1. 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, potentially pregnant, or lactating women.
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, severe psychological issues 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.

   Study Summary (anything necessary to note/ methods/ visit schedule)

   -Clinical Follow Ups : All Groups:

   • SOC visits @ 2 weeks, 3 months, 6 months, & 12 months Treatment Group:
   • (Standard of Care + Local Vancomycin + Local Tobramycin): Participants in the treatment group will receive a dose of 1000 mg of Vancomycin powder AND a dose of 1200 mg of Tobramycin powder in their wound bed immmediately before definitive wound closure at the time of definitive fracture fixation. Control Group:
   • (Standard of Care + Local Vancomycin): Participants in the control group will receive a dose of 1000 mg of Vancomycin powder in their wound bed immediately before definitive wound closure at the time of

     Payment:

   • $20 at 6 months
   • $20 at 12 months

Covered Expenses

• Surveys

• Vancomycin and Tobramycin Study Drugs

• Vancomycin and Tobramycin Study Drugs