Double-blind randomized clinical trial of vancomycin in spinal arthrodesis: no effects on surgical site infection.

OBJECTIVE:Surgical site infection (SSI) results in high morbidity and mortality in patients undergoing spinal fusion. Using intravenous antibiotics in anesthesia induction reduces the rate of postoperative infection, but it is not common practice to use them topically, despite recent reports that this procedure helps reduce infection. The objective of this study was to determine whether the topical use of vancomycin reduces the rate of postoperative SSI in patients undergoing thoracolumbar fusion. METHODS:A randomized, double-blind clinical trial in a single hospital was performed comparing vancomycin and placebo in thoracolumbar fusion patients. RESULTS:A total of 96 patients were randomized to placebo or vancomycin treatment. The mean patient age was 43 ± 14.88 years, 74% were male, and the most common etiology was fall from height (46.9%). The overall rate of postoperative SSI was 8.3%, and no difference was found between the groups: postoperative infection rates in the vancomycin and placebo groups were 8.2% and 8.5% (relative risk [RR] of SSI not using vancomycin 1.04, 95% confidence interval [CI] 0.28-3.93, p = 0.951), respectively. Patients with diabetes mellitus had higher SSI rates (RR 8.98, 95% CI 1.81-44.61, p = 0.007). CONCLUSIONS:This is the first double-blind randomized clinical trial to evaluate the effects of topical vancomycin on postoperative infection rates in thoracolumbar fusion patients, and the results did not differ significantly from placebo.Clinical trial registration no.: RBR-57wppt (ReBEC; http://www.ensaiosclinicos.gov.br/).