Does prophylactic local tobramycin injection lower open fracture infection rates?

Objective

To determine whether local aqueous tobramycin injection in combination with systemic perioperative IV antibiotic prophylaxis will reduce the rate of fracture-related infection (FRI) after open fracture fixation. Other Outcomes of Interest: (1) To compare fracture nonunion rates and report differences between treatment and control groups and (2) compare bacterial speciation and antibiotic sensitivity among groups that develop FRI.

Design

Phase 3 prospective, randomized clinical trial.

Setting

Two level 1 trauma centers.

Participants

Six hundred subjects (300 in study/tobramycin group and 300 in control/standard practice group) will be enrolled and assigned to the study group or control group using a randomization table. Patients with open extremity fractures that receive definitive internal surgical fixation will be considered. Intervention: Aqueous local tobramycin will be injected into the wound cavity (down to bone) after debridement, irrigation, and fixation, following closure. Main Outcome Measurements: Outcomes will look at the presence or absence of FRI, the rate of fracture nonunion, and determine speciation of gram-negative and Staph bacteria in each group with a FRI.

Results

Not applicable.

Conclusion

The proposed work will determine whether local tobramycin delivery plus perioperative standard antibiotic synergism will minimize the occurrence of open extremity FRI. Level of Evidence: Level 1.