CANCARE RESEARCH
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Topical Vancomycin for Prevention of Grade 2 or Higher Sternal Wound Infection After Cardiac Surgery: A Randomized Controlled Trial.
Clinical takeaway Topical vancomycin showed fewer grade 2 or higher sternal wound infections in this trial, but the hazard analysis and deep infection comparison were inconclusive; these findings do not establish overall safety.
Summary & abstract
Study summary
A single-center, prospective, single-blind trial randomized 360 adults undergoing elective full sternotomy cardiac surgery to topical vancomycin paste or normal saline. Grade 2 or higher sternal wound infection within 90 days occurred in 1 of 180 vancomycin recipients versus 7 of 180 controls (0.6% versus 3.9%; p = .031). The subdistribution hazard ratio was 0.14 (p = .065). Deep infection rates were 0.6% versus 2.8% (p = .099). Three vancomycin-resistant Enterococcus cases from various sources occurred among vancomycin recipients with chronic kidney disease stage 3 or higher or undergoing hemodialysis.
Study limitation: This single-center trial recorded few infection events, limiting precision; resistant-organism findings and systemic exposure in hemodialysis warrant caution.
Published abstract
BACKGROUND: To evaluate the efficacy and safety of topical vancomycin paste over the sternal edges in preventing sternal wound infection (SWI). METHODS: This single-center, prospective, single-blind controlled trial 1:1 randomized 360 adult patients undergoing elective full sternotomy cardiac surgery to receive either vancomycin paste or normal saline (NCT04500275). The primary endpoint was SWI within 90 postoperative days. The secondary endpoints included postoperative acute kidney injury, emergence of resistant pathogens and systemic vancomycin exposure. RESULTS: The incidence of grade 2 or higher SWI within 90 days was significantly lower in the vancomycin group than in the placebo group (1 of 180, 0.6% vs. 7 of 180, 3.9%, p = .031). The subdistribution hazard ratio was 0.14 (p = .065). Deep SWI rate was 0.6% vs. 2.8% (p = .099). The incidence of acute kidney injury was comparable between the groups (31.7% vs. 28.9%, p = .251), even in patients with CKD stages ≥ 3. Systemic vancomycin concentrations were negligible and declined over time in non-dialysis patients. Levels above 10-20 mg/L persisted in some patients undergoing hemodialysis. Three cases of vancomycin-resistant Enterococcus from various sources were observed in the vancomycin group of patients with CKD stage ≥ 3 or undergoing hemodialysis. CONCLUSIONS: Topical vancomycin reduced grade 2 or higher SWI without increasing the risk of acute kidney injury. Systemic exposure was negligible, except in patients undergoing hemodialysis. While the emergence of VRE cannot be excluded, its incidence was negligible and does not outweigh the benefits of SWI reduction when using topical vancomycin.
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