The Role of Vancomycin Powder to Prevent Wound Infection in Spine Surgery: Protocol of Randomized Control Trail

Abstract

IntrouductionPostoperative surgical site infection (SSI) continues to be an important problem after orthopedic procedures, especially spine surgery. Reported incidences of surgical-site infection among patients who undergo spine surgery range from 2% to 6% and > 10% after instrumented fusions. Postoperative surgical-site infection is associated with an important rate of complications and cost. One of the methods to decrees the incidence of SSI is using intrawound local vancomycin. The current evidence supporting the use of intra wound vancomycin powder in surgical wounds is limited and controversial Material and MethodsA prospective, single-center, randomized, parallel group controlled trial will conduct in orthopedic department, Hamad General Hospital. 198 patients, 18 years or older patients, will undergo to open spine surgery with or without instrumentation, will be randomly assigned to receive intrawound vancomycin as intervention group or systemic antibiotic (stander of care) as control group. Exclusion criteria include hypersensitivity to vancomycin, Immune compromised status, Unable to continue in follow up. ResultPrimary outcome is the incidence of wound infection after open spine surgery for adult patients, and the secondary outcomes are total infection-related medical cost compared with the cost of vancomycin powder, Adverse effects of local vancomycin, Length of hospitalization. Wound infection will assess according to ASEPSIS score. Results will be analyzed using SPSS software (SPSS), Differences between two groups (control-intervention) will be tested using of t-test, Fisher's exact test. ConclusionThe aim of this study is to detect the effectiveness of local vancomycin (intra-wound) in decreasing the post op surgical site infection in open spine surgery with or without instrumentation, and possible implanted as stander of care in Hamad General Hospital.