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腰椎融合术中粘贴条与缝线的比较:手术部位感染的非劣效性分析

Adhesive Strips vs. Sutures in Lumbar Spinal Fusion: A Non-inferiority Analysis of Surgical Site Infections.

作者信息

Núñez-Moreno Fernando A, Bepperling Christian, Trenado Carlos, Eitelbuss Steffen, Velázquez Karen, Karantzoulis Vasilis, Ochoa Estrada Maria C, Santos Edgar, Vazifehdan Farzam

机构信息

Spine Center, Diakonie-Klinikum Stuttgart, Stuttgart, DEU.

Institute of Clinical Neuroscience and Medical Psychology, Medical Faculty, Heinrich Heine University, Düsseldorf, DEU.

出版信息

Cureus. 2025 Apr 11;17(4):e82065. doi: 10.7759/cureus.82065. eCollection 2025 Apr.

Abstract

Introduction Surgical site infections (SSIs) continue to pose a significant challenge in spine surgery. Skin closure technique has been shown to impact SSI rates, with sutures traditionally considered the standard. Recently, alternative methods, such as adhesive strips, have gained attention for their potential advantages, including shorter operative times, fewer postoperative visits, and improved cosmetic outcomes. However, their efficacy in managing large surgical wounds, particularly in spine procedures, remains underexplored. This study compares SSI rates between sutures and adhesive strips in posterior one- and two-level lumbar spinal fusion using a non-inferiority design. Methods This single-center retrospective study evaluated SSI rates following lumbar spinal fusion using either sutures or adhesive strips for skin closure. Patients who underwent one- or two-level lumbar fusion via an open posterior approach between 2019 and 2022 were initially identified (n = 1,051). Following the application of predefined exclusion criteria, 997 patient records were eligible for review. Propensity score matching (PSM) was then employed to balance key covariates, such as age, sex, ASA classification, surgical time, use of drainage, and the number of levels fused, resulting in 608 patients evenly allocated into two groups. Data were extracted from a prospectively maintained institutional database, and SSIs were classified using the German Krankenhaus Infektions Surveillance System (KISS). A non-inferiority margin of 3% (absolute risk difference) was applied to compare SSI rates. Statistical analyses included t-tests, Mann-Whitney U tests, chi-square tests, and a Wald test for non-inferiority, with the non-inferiority established if the upper bound of the one-sided 95% confidence interval (CI) remained below the 3% margin. Results Following PSM, infection rates within a 30-day postoperative follow-up were 1.64% in the suture group and 1.97% in the adhesive strip group. A one-sided Wald test, using a 3% non-inferiority margin, yielded an absolute risk difference of 0.33% (SE = 1.1%; z = -2.47; one-sided p = 0.0067), with the upper bound of the 95% CI at 2.11%. Conclusion Adhesive strips demonstrated non-inferiority to sutures in terms of SSI rates following one- or two-level lumbar spinal fusion and may offer the added benefit of reduced operative time. However, further research is warranted to confirm these findings and support the broader implementation of adhesive strips in spinal fusion procedures.

摘要

引言

手术部位感染(SSIs)在脊柱手术中仍然是一个重大挑战。皮肤闭合技术已被证明会影响手术部位感染率,传统上认为缝合是标准方法。最近,诸如粘贴带等替代方法因其潜在优势而受到关注,这些优势包括手术时间更短、术后复诊次数更少以及美容效果更好。然而,它们在处理大型手术伤口方面的疗效,特别是在脊柱手术中,仍未得到充分研究。本研究采用非劣效性设计比较了在单节段和双节段腰椎后路融合手术中使用缝合线和粘贴带后的手术部位感染率。

方法

这项单中心回顾性研究评估了使用缝合线或粘贴带进行皮肤闭合的腰椎融合术后的手术部位感染率。最初确定了2019年至2022年间通过开放后路进行单节段或双节段腰椎融合的患者(n = 1,051)。应用预定义的排除标准后,997份患者记录符合审查条件。然后采用倾向得分匹配(PSM)来平衡关键协变量,如年龄、性别、美国麻醉医师协会(ASA)分级、手术时间、引流使用情况以及融合节段数,最终将608名患者平均分为两组。数据从一个前瞻性维护的机构数据库中提取,手术部位感染按照德国医院感染监测系统(KISS)进行分类。采用3%(绝对风险差异)的非劣效性界值来比较手术部位感染率。统计分析包括t检验、曼-惠特尼U检验、卡方检验以及非劣效性的 Wald 检验,如果单侧95%置信区间(CI)的上限保持在3%界值以下,则确定为非劣效。

结果

倾向得分匹配后,缝合线组术后30天随访内的感染率为1.64%,粘贴带组为1.97%。使用3%非劣效性界值的单侧Wald检验得出绝对风险差异为0.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da0b/12066879/6eafe52b80f4/cureus-0017-00000082065-i01.jpg

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