Epidemiology, Medical Devices; Johnson & Johnson; 410 George Street, New Brunswick, NJ, USA.
Pre-Clinical & Clinical Research, Medical Affairs; DePuy Synthes Spine; 325 Paramount Drive, Raynham, MA, USA.
Spine J. 2021 Jan;21(1):45-54. doi: 10.1016/j.spinee.2020.08.017. Epub 2020 Sep 3.
Spinal fusion surgeries are one of the most common types of operations performed during inpatient stays in the United States. Successful wound closure, including watertight closure at the skin layer, plays in important role in patient outcomes.
To compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (SSWWD) or 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT).
STUDY DESIGN/SETTING: Retrospective study using a multi-hospital database.
Patients undergoing inpatient spinal fusion surgery for a spine disorder between October 1, 2015 and March 31, 2019.
Total costs from the hospital perspective, operating room time (ORT), hospital length of stay (LOS), non-home discharge, infection/wound complications during the 90-day global period (index surgery through 90 days post-discharge), and 30/60/90-day all-cause readmissions.
Outcomes were compared between study groups using nearest neighbor propensity score matching with exact matching on 45 primary procedure/diagnosis code groupings and generalized estimating equations to account for hospital-level clustering. This study was sponsored by Ethicon, Inc., a Johnson & Johnson company; the authors are employees or consultants of Johnson & Johnson.
A total of 11,991 patients met the study criteria (2OPMT=5,961; SSWWD=6,030), of which 3,602 were included in each post-match study comparison group (total=7,204). As compared with the SSWWD group, the 2OPMT group had statistically significant lower median ORT (240 vs. 270 minutes; p=0.002), mean LOS (3.35 [SD=2.6] vs. 3.86 [SD=2.8] days, p=0.031), risks of non-home discharge status (17.63% vs. 23.10%, p=0.035), overall infections/wound complications (1.37% vs. 2.48%, p=0.015), and surgical site infection (1.11% vs. 2.07%, p=0.023). Differences between the study groups in total hospital costs, all-cause readmissions, and other sub-components of the infection/wound complication composite outcome were statistically insignificant (p>0.05).
In this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2OPMT for skin closure was associated with significantly lower ORT, LOS, non-home discharge, and 90-day rates of infections/wound complications as compared with SSWWD.
脊柱融合手术是美国住院患者最常见的手术类型之一。成功的伤口闭合,包括皮肤层的防水闭合,对患者的预后起着重要作用。
比较两种无缝线皮肤闭合技术之一(皮肤钉加防水伤口敷料[SSWWD]或 2-辛基氰基丙烯酸酯加聚合物网带[2OPMT])在脊柱融合手术中的经济和临床结果。
研究设计/设置:使用多医院数据库进行回顾性研究。
2015 年 10 月 1 日至 2019 年 3 月 31 日期间因脊柱疾病接受住院脊柱融合手术的患者。
从医院角度计算的总费用、手术室时间(ORT)、住院时间(LOS)、非家庭出院、90 天全球期内(索引手术至出院后 90 天)的感染/伤口并发症,以及 30/60/90 天全因再入院。
使用最近邻居倾向评分匹配,对 45 个主要手术/诊断代码组进行精确匹配,并使用广义估计方程来考虑医院水平的聚类,对研究组之间的结局进行比较。本研究由 Ethicon,Inc.(Johnson & Johnson 公司的子公司)赞助;作者是 Johnson & Johnson 的员工或顾问。
共有 11991 名患者符合研究标准(2OPMT=5961;SSWWD=6030),其中 3602 名患者被纳入每组的匹配后研究比较组(总计=7204)。与 SSWWD 组相比,2OPMT 组的中位 ORT(240 分钟比 270 分钟;p=0.002)、平均 LOS(3.35[SD=2.6]比 3.86[SD=2.8]天,p=0.031)、非家庭出院状态的风险(17.63%比 23.10%,p=0.035)、整体感染/伤口并发症的风险(1.37%比 2.48%,p=0.015)和手术部位感染的风险(1.11%比 2.07%,p=0.023)显著降低。研究组在总住院费用、全因再入院率和感染/伤口并发症复合结局的其他亚组方面无统计学差异(p>0.05)。
在这项对接受择期住院脊柱融合手术的患者进行的回顾性观察性研究中,与 SSWWD 相比,使用 2OPMT 进行皮肤闭合与 ORT、LOS、非家庭出院和 90 天内感染/伤口并发症的发生率显著降低有关。