Authors: Diana Tang Ruan; Sophie Ulene; Brandon Christophe; Alison Clarke; E. Connolly, MD (New York, NY)
Surgical site infections (SSIs) following craniotomy procedures are associated with worse outcomes and higher costs. Application of topical vancomycin prior to wound closure has decreased SSI rates in spine, cardiac, and ophthalmologic procedures, while minimizing systemic exposure to vancomycin. Here, we assess the efficacy of topical vancomycin in reducing SSIs in craniotomy patients.
As of August 1st, 2018, 970 craniotomy patients at New York Presbyterian-Columbia and Cornell were enrolled and 758 interviewed in this ongoing multi-center, patient-blinded randomized controlled trial. Subjects were randomized to Cohort I, which received IV cefazolin, or to Cohort II, which received IV cefazolin and 2 g topical vancomycin. Follow-up phone interviews were conducted to screen for SSIs within 30 and 90-days post-operation (POD). Primary outcomes were defined as antibiotic prescription for suspected SSI (probable) or positive skin culture with/without SSI-related hospital readmission (confirmed).
Among 378 Cohort I subjects (50.1%) interviewed at POD 30, SSI rates were 1.85% probable and 0.8% confirmed. The 367 Cohort II patients (49.9%) interviewed at POD 30 had rates of 0.53% probable and 1.1% confirmed (RR 1.05; 0.27, 4.19, p=0.9399; NNT=1,775). Of 123 Cohort I subjects (50.6%) interviewed at POD 90, SSI rates were 0.8% probable and 0.8% confirmed. Among the 120 Cohort II subjects (49.4%) interviewed at POD 90, SSI rates were 0% probable and 0.8% confirmed SSIs (RR 1.03; 0.06, 16.20, p=0.986; NNT=4,920).
Both POD 30 and 90 follow-up data show no significant difference in confirmed SSIs between the two cohorts, which may be attributable to low baseline infection rates at the study sites relative to centers included in published literature. While the trial is ongoing, initial analysis suggests a larger cohort and greater site diversity may be necessary to observe a significant decrease in craniotomy SSIs following prophylactic application of topical vancomycin.