Randomized, Controlled, Single-blinded Trial to Evaluate the Efficacy and Safety of Intra-wound Vancomycin Powder as Add-on Prophylactic Intraoperative Antibiotic for High-risk Open Posterior Spinal Surgery

Dr Cheung, Jason Pui Yin   (Principal Investigator (PI))

Professor Cheung Kenneth Man Chee   (Co-Investigator)

Dr Ho Pak Leung   (Co-Investigator)

36

2022-01-01

1492928

Randomized, Controlled, Single-blinded Trial to Evaluate the Efficacy and Safety of Intra-wound Vancomycin Powder as Add-on Prophylactic Intraoperative Antibiotic for High-risk Open Posterior Spinal Surgery

Randomized controlled trial, Spine surgery, Surgical site infection, vancomycin

Others - Medicine, Dentistry and Health

08192016

Health and Medical Research Fund - Full Grant

2020

On-going

Objectives: To determine whether intrawound vancomycin powder reduces the rate of surgical site infections in high-risk open posterior spinal surgery, and its safety profile and cost-effectiveness. Hypothesis to be tested: Local application of vancomycin powder is clinically effective and cost-effective in reducing surgical site infection rates in deformity, trauma and tumor surgery, and does not increase risks of adverse events, nonunion and gram negative and polymicrobial infections. Design and subjects: Randomized controlled trial of 148 patients undergoing high-risk open posterior spinal surgery. Adaptive study design with an interim analysis for any sample size re-estimation. Instruments: Parameters include age, gender, BMI, smoking and drinking history, co-morbidities, pathology, location and instrumented spinal levels of surgery, serum albumin, basic mobility score, duration of surgery, adverse events. Radiographs and computed tomography are obtained. Interventions: Patients are randomized into the treatment group where 1g of vancomycin powder is administered intraoperatively to the deep and superficial spinal wound, and the control group without vancomycin. Main outcome measures: Primary outcome is the rate of surgical site infection. Secondary outcomes include any adverse effects, 1-year fusion rates assessed by radiographs and computed tomography, and type of organisms cultured from infected cases. Data analysis: Baseline comparison with Student’s t-test or Wilcoxon Rank-Sum test for continuous variables and Chi-square or Fisher’s exact test for categorical/discrete variables. Efficacy analysis by multiple logistic regression according to intention-to-treat and per-protocol principles. Expected results: Local administration of vancomycin powder reduces surgical site infections in high-risk open posterior spinal surgery.