Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures

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 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.

Local Application of Vancomycin in Orthopaedic Surgery—A Review

“…The primary outcome measure was a deep SSI within 182 days of surgery, and the study found that the use of VP reduced the risk of grampositive deep SSIs only. The risk difference when delineated by gram-positive infections was significant for the VPreceiving group to observe a risk difference or reduction of 3.7% when using VP (p 5 0.02); the risk difference for gramnegative infections was not statistically significant (p 5 0.78) 42 .…”

Local Antibiotic Delivery Options in Prosthetic Joint Infection

“…Studies are limited with no randomised controlled trials (RCT), and results of recent meta-analyses are conflicting as to whether PJI risk is reduced [ 35 , 36 ]. Vancomycin powder has been shown to significantly reduce the gram-positive deep surgical site infection rate in an RCT of high-risk tibial articular fractures [ 37 ]. It has also been shown to be protective against surgical site infection in spinal surgery on meta-analysis [ 38 ].…”

Current Concept Review: Risk Factors for Infection Following Open Fractures

“…The control group within the study had a 10.6% infection rate. 40 Local antibiotics appear to decrease the risk of infection following open fracture. However, several concerns exist.…”