As we hypothesized, the combination of systemic cefazolin and local gentamicin proved to be the most effective regimen. Local injection of gentamicin proved more effective than systemic administration of cefazolin but was not as effective as the combination of both antibiotics. The initially high concentrations of locally applied antibiotic and the utilization of two different classes of antibiotics may have contributed to the observed efficacy.

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The gentamicin-loaded calcium sulfate flakes did not result in bacterial counts that were significantly lower than those following systemic administration of gentamicin, which refuted our hypothesis. However, gentamicin solution injected directly into the closed wound did result in levels of bacteria that were significantly lower than those following treatment with the systemic gentamicin.

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The previously recognised trend of increasing use of IMN for IT femur fractures has continued. The overall incidence of operative IT femur fractures is not increasing at this time. The cost of IMN remains higher than SHS.

Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

IMPORTANCE Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist.OBJECTIVE To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. DESIGN, SETTING, AND PARTICIPANTSThis open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers.INTERVENTIONS A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. MAIN OUTCOMES AND MEASURESThe primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. RESULTSThe analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections.CONCLUSIONS AND RELEVANCE Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin.