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Original Investigation
March 24, 2021

Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial

The Major Extremity Trauma Research Consortium (METRC)
JAMA Surg. Published online March 24, 2021. doi:10.1001/jamasurg.2020.7259
Key Points

Question  Does intrawound vancomycin powder reduce deep surgical site infections in patients with high-risk tibial plateau and pilon fracture?

Findings  In this randomized clinical trial of 980 patients, intrawound vancomycin reduced deep surgical site infection rates by 3.4%. A post hoc analysis found that this effect was a result of a reduction in gram-positive infections.

Meaning  These findings suggest that intrawound vancomycin powder is a promising low-cost, low-risk intervention for reducing deep surgical site infections, particularly those with gram-positive organisms.

Abstract

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 Participants  This 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 Measures  The 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.

Results  The 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.

Trial Registration  ClinicalTrials.gov Identifier: NCT02227446

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    1 Comment for this article
    Bone healing
    Felix Blaesius, M.D. | University Hospital RWTH Aachen, Germany
    Dear Authors,

    you have included fractures with a high risk of infection. In particular, the open fractures are subject to a high risk of delayed bone healing or fracture nonunion. To what extent locally applied vancomycin affects bone healing is unknown, but an important observation. A lower infection rate should not be "bought" with a higher rate of delayed bone healing or fracture nonunion. Do you have data on healing rates from your study that you could present? That would be very helpful in the evaluation of the study.

    Yours sincerely,
    F. Bläsius
    CONFLICT OF INTEREST: None Reported
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