Tobramycin Injection to Prevent Infection in Open Fractures
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
The goal of open extremity fracture (OEF) treatment is to promote fracture healing and
restore function while preventing the development of infection. This is achieved through
systematic and timely wound debridement and irrigation, fracture stabilization, tetanus
prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure
based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open
fractures but have limitations of achieving adequate concentration at the hypoperfused wound
area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury,
hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic
antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for
pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp
contrast, locally administered antibiotics achieve high drug concentration directly within
the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to
reduce rates of open fracture wound infection. With the serious implications of postoperative
infections in OEF, it is imperative that all measures including further use of prophylactic
local antibiotics be considered to prevent fracture-related infection (FRI). The overarching
hypothesis for this project is that a novel synergistic combination of local aqueous
tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will
reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient
outcomes, decreasing morbidity and return to the operating room (OR) without any adverse
effect on fracture healing. Regardless of the treatment group, bacterial speciation will be
determined for patients that do develop FRI to help guide future treatment. The goal is to
improve the clinical outcome and recovery of the population that sustains an OEF by
decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial
speciation and resistance.