Assessing use of vancomycin powder in craniotomy: randomized controlled trial (AVIC)

Abstract

Background: Surgical-site infections (SSIs) can lead to greater postoperative morbidity, mortality, and health care costs. Despite current prophylactic measures, rates of SSIs have been reported in up to 5% of patients post craniotomy. Intrawound vancomycin powder has been studied extensively in spinal fusion surgeries and been found to reduce rates of surgical site infections (SSIs) significantly. Despite its success in spinal surgeries, topical vancomycin has not been extensively studied with respect to cranial neurosurgery. Methods: Our study is Prospective Randomized clinical trial. Patients will be divided in this Trial into two groups, first group (intervention arm) they will receive the drug (vancomycin) in the wound before the closure of the skin at the end of the surgical procedure. The second group (control arm) they will not receive the drug, otherwise both groups they will receive identical measure to decrease the postoperative SSI. The primary outcome variable will be SSI rate factored by cohort. Secondary outcome will be to monitor the safety and any complication related to the use of vancomycin . SSI found to be around 0.49% when vancomycin was used, while SSI in standard care found to be 5%, to get power of study 80% and level of significance 5%. Sample size will be 250 in each group using sample size calculator. Discussion: This study is designed to evaluate the efficacy of vancomycin compared to standard method in neuro-surgical cases undergoing craniotomy . Additionally, safety of vancomycin will be assessed in these patients.