Real World Data Analytics and Research, Medical Devices - Epidemiology, Johnson & Johnson, New Brunswick, NJ, USA.
Franchise Health Economics and Market Access, Ethicon, Johnson & Johnson, Somerville, NJ, USA.
J Matern Fetal Neonatal Med. 2021 Jun;34(11):1711-1720. doi: 10.1080/14767058.2019.1645830. Epub 2019 Aug 1.
To compare clinical and economic outcomes of cesarean deliveries with skin closure through skin staples plus waterproof wound dressings (SSWWD) versus 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT). We hypothesized that cesarean deliveries with skin closure through 2OPMT may be associated with a lower rate of wound complications and infections as compared with skin closure through SSWWD; we also hypothesized that, accordingly, 2OPMT may be associated with lower hospital length of stay (LOS), hospital costs, and all-cause readmissions as compared with SSWWD.
Retrospective, observational study using a research database derived from administrative records routinely contributed by hundreds of hospitals in the USA. We queried the database for patients aged 18-49 years who had an in-hospital low transverse cesarean delivery between 1 January, 2012 and 31 March, 2017. Using records of medical supplies used during deliveries, we identified deliveries for which skin closure was performed by either SSWWD (SSWWD group) or 2OPMT (2OPMT group). Our primary study outcome was a composite endpoint of infection/wound complication diagnosis during the hospital stays in which the deliveries were performed. Our secondary outcomes included: length of stay (LOS) and total hospital costs for the hospital stays in which the deliveries were performed, and all-cause readmissions (30/60/90 days post discharge) to the same hospital in which the delivery was performed. We compared outcomes between propensity-score matched groups using regressions accounting for hospital-level clustering and non-Gaussian empirical outcome distributions.
Each group comprised 2133 patients (4266 total patients; mean age = 30.3 years [SD = 4.6]). Compared with the SSWWD group, the 2OPMT group had statistically significant lower rates of complications (infection, 0.7 versus 1.6%, = .011; wound complication, 0.6 versus 1.3%, = .036; composite, 0.9 versus 2.0%, = .002), shorter LOS (mean = 3.5 days [SD = 1.6] versus 3.7 days [SD = 1.8], = .007), and lower total hospital costs (mean = $8879 [SD = $3157] versus $9313 [SD = $3311], = .025). Between-group differences for 30/60/90-day all-cause readmissions were statistically insignificant.
This large observational study is the first of its kind and provides evidence that cesarean delivery skin closure with 2OPMT is associated with lower rates of in-hospital infection and wound complications, lower LOS, lower total hospital costs as compared with SSWWD.
比较经皮钉合加防水伤口敷料（SSWWD）与 2-辛基氰基丙烯酸酯加聚合物网带（2OPMT）缝合切口的剖宫产术的临床和经济结局。我们假设与 SSWWD 相比，2OPMT 缝合切口可能与较低的伤口并发症和感染发生率相关；我们还假设与 SSWWD 相比，2OPMT 可能与较低的住院时间（LOS）、住院费用和全因再入院率相关。
使用源自美国数百家医院常规提供的行政记录的研究数据库进行回顾性观察性研究。我们从数据库中查询了年龄在 18-49 岁之间、2012 年 1 月 1 日至 2017 年 3 月 31 日期间在医院行横切口剖宫产术的患者记录。使用分娩过程中使用的医疗用品记录，我们确定了使用 SSWWD（SSWWD 组）或 2OPMT（2OPMT 组）缝合切口的分娩。我们的主要研究结果是在分娩期间发生的感染/伤口并发症诊断的复合终点。我们的次要结果包括：分娩期间住院的 LOS 和总住院费用，以及在出院后 30/60/90 天到同一医院的全因再入院率。我们使用回归分析比较了倾向评分匹配组之间的结果，该分析考虑了医院水平的聚类和非正态经验结果分布。
每组均包括 2133 名患者（4266 名患者；平均年龄为 30.3 岁[标准差=4.6]）。与 SSWWD 组相比，2OPMT 组的并发症发生率较低（感染：0.7% vs. 1.6%， =.011；伤口并发症：0.6% vs. 1.3%， =.036；复合：0.9% vs. 2.0%， =.002），住院时间更短（平均=3.5 天[标准差=1.6] vs. 3.7 天[标准差=1.8]， =.007），总住院费用更低（平均=8879 美元[标准差=3157 美元] vs. 9313 美元[标准差=3311 美元]， =.025）。两组之间 30/60/90 天全因再入院率的差异无统计学意义。
这项大型观察性研究是同类研究中的首例，提供了证据表明与 SSWWD 相比，使用 2OPMT 缝合剖宫产术的皮肤切口与较低的院内感染和伤口并发症发生率、较短的住院时间、较低的总住院费用相关。
