Topical Vancomycin for Prevention of Grade 2 or Higher Sternal Wound Infection After Cardiac Surgery: A Randomized...

To evaluate the efficacy and safety of topical vancomycin paste over the sternal edges in preventing sternal wound infection (SWI).

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.

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.

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.