The efficacy and safety of intrawound vancomycin powder to prevent surgical site infection in adult scoliosis surgery (Vanco-SSIASS): study protocol for a prospective, randomized controlled, assessor‑blinded, open‑label, multicenter trial.

BACKGROUND

Postoperative surgical site infections (SSIs) following adult scoliosis deformity (ASD) correction surgery are receiving more attention globally. Intrawound vancomycin powder in spinal surgical wounds has emerged as a promising strategy to prevent SSIs in recent years. However, the efficacy and safety of intrawound vancomycin powder in preventing SSIs following ASD correction surgery are still very controversial. This protocol describes a prospective, randomized controlled, multicenter clinical trial aimed at verifying vancomycin's efficacy and safety.

METHODS

This is a study protocol for multicenter randomized controlled trial on efficacy and safety of intrawound vancomycin powder in preventing SSIs after ASD correction surgery. Eligible ASD patients (n = 264) will be recruited from the orthopedic inpatients of three university-affiliated medical centers in China. They will be randomly assigned to receive either standard perioperative anti-SSIs treatment (control group, n = 132), or 1000 mg vancomycin for spray injection on the surgical site during the correction surgery with standard perioperative anti-SSIs treatment (intervention group, n = 132) using a block randomization method.

DISCUSSION

Up to now, there is no RCT (randomized controlled trial) to investigate the efficacy and safety of intrawound vancomycin powder to prevent surgical site infection in adult scoliosis surgery. We believe the RCT introduced in the article will fill the gap in this field and guide the perioperative anti-infection clinical medication for adult spinal deformity correction surgery.

TRIAL REGISTRATION

ChiCTR2200059883. Registered on May 13, 2022. https://www.chictr.org.cn/showproj.html?proj=166621.