Major Extremity Trauma and Rehabilitation Consortium (METRC): Topical Antibiotic Therapy to Reduce Infection after Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial Department of Orthopaedic Surgery and Rehabilitation | College of Medicine – Jacksonville

Major Extremity Trauma and Rehabilitation Consortium (METRC): Topical Antibiotic Therapy to Reduce Infection after Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial

Study Description

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) to reduce deep surgical site infections in patients with tibial plateau and tibial pilon fractures at high risk of infection.

Inclusion/Exclusion Criteria

Inclusion criteria:

1. Individuals with tibial plateau and tibial pilon fractures that are undergoing surgery with plate and screw fixation AND have 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 fracture

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

Exclusion criteria:

1. Injury is already infected at time of enrollment

Investigators

Massimo Morandi, M.D., FACS
Orthopaedic Surgery and Rehabilitation