Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

Background: This study addresses the Clinical Trial Award (CTA) focus area of Translation of early research findings under the category of fracture related infection (FRI). Open extremity fractures (OEFs) sustained from traumatic injuries are higher risk for FRI and nonunion due to damage of the soft tissues, impaired bone vascularity and healing, and diminished host defenses against bacteria. Hypothesis/Objective: This study tests the hypothesis that administering a local dose of tobramycin injection in combination with systemic perioperative intravenous (IV) antibiotic prophylaxis will reduce the rate of FRI one year after OEF fixation surgery. This study will also determine bacterial speciation and antibiotic sensitivity among study patients who develop FRI, as well as nonunion status among all participants. Specific Aims: Aim 1: Determine if a local dose of tobramycin (2 mg/mL) injection in combination with systemic perioperative IV antibiotic prophylaxis will reduce the rate of FRI one year after OEF fixation surgery. Aim 2: Determine if local tobramycin injection has a negative effect on OEF union. Aim 3: Compare bacterial speciation and antibiotic sensitivity among study patients who develop FRI between the control and treatment groups. Study Design: This is a randomized clinical trial that will enroll 600 participants (300 in the control cohort, and 300 in the treatment cohort) over a three-year period at two Level I trauma centers, with the final year dedicated to data interpretation. The primary outcome will be presence or absence of FRI, while secondary outcomes will be nonunion status, bacterial speciation and antibiotic sensitivity in patients that develop FRI. The patients will be followed for one year to determine outcomes of interest.