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
Abstract 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, t...
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BMC
2025-08-01
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| Online Access: | https://doi.org/10.1186/s13063-025-09000-8 |
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| author | Bo Han Yong Hai Yihan Yang Weishi Liang Yan Yu Tao Guo Duan Sun Zhangfu Li Shuilian Chu Peng Yin |
| author_facet | Bo Han Yong Hai Yihan Yang Weishi Liang Yan Yu Tao Guo Duan Sun Zhangfu Li Shuilian Chu Peng Yin |
| author_sort | Bo Han |
| collection | DOAJ |
| description | Abstract 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 |
| format | Article |
| id | doaj-art-229ec6cdab4d4a7da2a0d208e80b0d97 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-229ec6cdab4d4a7da2a0d208e80b0d972025-08-20T04:03:07ZengBMCTrials1745-62152025-08-0126111410.1186/s13063-025-09000-8The 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 trialBo Han0Yong Hai1Yihan Yang2Weishi Liang3Yan Yu4Tao Guo5Duan Sun6Zhangfu Li7Shuilian Chu8Peng Yin9Department of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Spine Surgery, Tongji Hospital, Tongji UniversityDepartment of Orthopaedic, Guizhou Provincial People’s HospitalDepartment of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Clinical Epidemiology, Institute of Respiratory Medicine, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Orthopaedic, Beijing Chaoyang Hospital, Capital Medical UniversityAbstract 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=166621https://doi.org/10.1186/s13063-025-09000-8Adult scoliosis deformity (ASD)Surgical site infections (SSIs)VancomycinIntrawoundEfficacySafety |
| spellingShingle | Bo Han Yong Hai Yihan Yang Weishi Liang Yan Yu Tao Guo Duan Sun Zhangfu Li Shuilian Chu Peng Yin 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 Trials Adult scoliosis deformity (ASD) Surgical site infections (SSIs) Vancomycin Intrawound Efficacy Safety |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Adult scoliosis deformity (ASD) Surgical site infections (SSIs) Vancomycin Intrawound Efficacy Safety |
| url | https://doi.org/10.1186/s13063-025-09000-8 |
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