Surgical site infection (SSI) is a very common complication of emergency laparotomy and causes significant morbidity. The PICO◊ device delivers negative pressure wound therapy (NPWT) to closed incisions, with some studies suggesting a role for prevention of SSI in heterogenous surgical populations. We aimed to compare SSI rates between patients receiving PICO◊ versus conventional dressing post-emergency laparotomy. Secondary objectives were to observe seroma and dehiscence rates, length of stay, days on dressing and patients’ wound experience. This double blinded randomized controlled trial was conducted in University Malaya Medical Centre between October 2019 and March 2022. Patients undergoing emergency laparotomy requiring incisions less than 35 cm were included. Statistical analysis was performed using χ2 test for categorical variables, independent T-test or Mann–Whitney U were used for parametric or non-parametric data respectively besides logistic regression. P values of < 0.05 were considered to be significant. Ninety-six patients were analyzed (47 interventions, 49 controls). The duration on dressing was more consistent in the intervention arm (PICO◊) versus control arm [9.78 ± 10.20 vs 17.78 ± 16.46 days, P < 0.001]. There was a trend towards lower SSI [14.3 vs 4.3%, P = 0.09], dehiscence [27.1 vs 10.6%, P = 0.07] and seroma [40.8 vs 23.4%, P = 0.08] rates in the intervention arm but this did not reach statistical significance. Length of stay [9 (IQR: 6–14) vs 11 (IQR: 6–22.5) days, P = 0.18] was fairly similar between the two arms, but more patients were very satisfied with PICO◊ compared to the conventional dressing [80% vs 57.1%, P = 0.03]. The use of NPWT in emergency laparotomy improves patients wound care experience, and was associated with trends towards fewer wound related complications. Cost effectiveness needs to be explored in order to further validate its use in the emergency setting, especially for patients with additional risk for SSI. Trial registration National Medical Research Registry (NMRR): NMRR-20-1975-55222.

中文翻译：

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预防性 PICO◊ 敷料缩短了紧急剖腹手术后伤口敷料的要求（EL-PICO◊ 试验）


手术部位感染 （SSI） 是急诊剖腹手术中非常常见的并发症，可导致严重的并发症。PICO◊ 装置将负压伤口治疗 （NPWT） 输送到闭合切口，一些研究表明在异质性手术人群中具有预防 SSI 的作用。我们旨在比较急诊剖腹术后接受 PICO◊ 与传统敷料的患者的 SSI 发生率。次要目标是观察血清肿和裂开率、住院时间、穿药天数和患者的伤口体验。这项双盲随机对照试验于 2019 年 10 月至 2022 年 3 月在马来亚大学医学中心进行。纳入接受急诊剖腹手术且切口小于 35 cm 的患者。分类变量采用 χ2 检验进行统计分析，除 logistic 回归外，参数或非参数数据分别采用独立 T 检验或 Mann-Whitney U。< 的 P 值 0.05 被认为是显著的。分析了 96 名患者 （47 项干预，49 名对照）。干预组 （PICO◊） 与对照组的敷料持续时间更一致 [9.78 ± 10.20 vs 17.78 ± 16.46 天，P < 0.001]。干预组有降低 SSI [14.3 vs 4.3%，P = 0.09]、裂开 [27.1 vs 10.6%，P = 0.07] 和血清肿 [40.8 vs 23.4%，P = 0.08] 的趋势，但这没有达到统计学意义。两组之间的住院时间 [9 （IQR： 6-14） vs 11 （IQR： 6-22.5） 天，P = 0.18] 相当相似，但与传统敷料相比，更多患者对 PICO◊ 非常满意 [80% vs 57.1%，P = 0.03]。 在紧急剖腹手术中使用 NPWT 可改善患者的伤口护理体验，并且与伤口相关并发症减少的趋势相关。需要探索成本效益，以便进一步验证其在紧急情况下的使用，特别是对于具有 SSI 额外风险的患者。试验注册国家医学研究登记处 （NMRR）：NMRR-20-1975-55222。