Han Bo, Hai Yong, Yang Yihan, Liang Weishi, Yu Yan, Guo Tao, Sun Duan, Li Zhangfu, Chu Shuilian, Yin Peng
Department of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical University, No. 8 Gong Ti Nan Road, Chaoyang District, Beijing, 100020, China.
Joint Laboratory for Research and Treatment of Spinal Cord Injury in Spinal Deformity, Capital Medical University, Beijing, 100071, China.
Trials. 2025 Aug 5;26(1):273. doi: 10.1186/s13063-025-09000-8.
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.
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.
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.
ChiCTR2200059883. Registered on May 13, 2022. https://www.chictr.org.cn/showproj.html?proj=166621.
成人脊柱侧弯畸形（ASD）矫正手术后的手术部位感染（SSIs）在全球范围内受到越来越多的关注。近年来，脊柱手术伤口内使用万古霉素粉末已成为预防手术部位感染的一种有前景的策略。然而，伤口内使用万古霉素粉末预防ASD矫正手术后手术部位感染的有效性和安全性仍存在很大争议。本方案描述了一项前瞻性、随机对照、多中心临床试验，旨在验证万古霉素的有效性和安全性。
这是一项关于伤口内使用万古霉素粉末预防ASD矫正手术后手术部位感染有效性和安全性的多中心随机对照试验的研究方案。符合条件的ASD患者（n = 264）将从中国三家大学附属医院骨科住院患者中招募。他们将被随机分配接受标准围手术期预防手术部位感染治疗（对照组，n = 132），或在矫正手术期间在手术部位喷雾注射1000 mg万古霉素并接受标准围手术期预防手术部位感染治疗（干预组，n = 132），采用区组随机化方法。
到目前为止，尚无随机对照试验（RCT）研究伤口内使用万古霉素粉末预防成人脊柱侧弯手术手术部位感染的有效性和安全性。我们相信本文介绍的RCT将填补该领域的空白，并指导成人脊柱畸形矫正手术围手术期抗感染临床用药。
ChiCTR2200059883。于2022年5月13日注册。https://www.chictr.org.cn/showproj.html?proj=166621。
