RESUMO
BACKGROUND: The use of topical vancomycin in the reduction of sternal wound infection (SWI) risk has become a point of contention. The earlier literature consists of observational studies and 1 unblinded trial. Hence, the objective of this study was to assess whether vancomycin reduces the incidence of SWI in a double-blind randomized controlled trial. METHODS: Patients were randomized 1:1 to either vancomycin-soaked (vancomycin) or saline-soaked (control) sponges. The sponges were applied once the sternum was opened and were removed just before sternal closure. Patients were followed up at 3 months and at 1 year postoperatively to determine the incidence of SWI in each group. Results were analyzed according to the modified intention-to-treat principle. RESULTS: This study assessed 1038 patients for eligibility and enrolled 1037 patients. There were 517 patients randomized to the vancomycin group and 520 patients randomized to the control group. Analysis was performed on 1021 patients. At 3 months postoperatively, there was no significant difference in the incidence of SWI between the vancomycin and control groups (2.7% vs 4.1%; P = .23). There was also no significant difference between the vancomycin and control groups in the risk of superficial, deep, and organ-space infections. Similar findings were observed 1 year postoperatively. The most common organism isolated was coagulase-negative Staphylococcus. CONCLUSIONS: The use of vancomycin applied to the sternum during cardiac surgery does not reduce the incidence of SWI.
