为预防腹部手术后手术部位感染，标准护理与标准护理相结合的护理包（EPO2CH试验）：一项随机、开放标签、实用、优势的多中心试验

IF 13 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2025-09-17 DOI:10.1016/j.lanepe.2025.101448

Niels Wolfhagen , Quirine J.J. Boldingh , Wouter J. Bom , Linda M. Posthuma , Jochem C.G. Scheijmans , Bart M.F. van der Leeuw , Joost A.B. van der Hoeven , Jens-Peter Hering , Dirk J.A. Sonneveld , Otto E. van Geffen , Eduard R. Hendriks , Ewoud B. Kluyver , Ahmet Demirkiran , Luc R.C.W. van Lonkhuijzen , Marcel G.W. Dijkgraaf , Markus W. Hollmann , Marja A. Boermeester , Stijn W. de Jonge

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引用次数: 0

摘要

手术部位感染（SSI）是常见的。我们从最近的SSI预防指南中选择了五种干预措施，形成了围手术期护理和健康强化计划（EPO2CH），这是一个围手术期护理包。我们的目的是研究EPO2CH束对SSI发生率的影响。方法EPO2CH试验是一项开放标签、实用、随机对照平行组多中心试验，在该试验中，我们将计划进行切口大于5厘米的择期腹部手术的患者分配到标准护理组或标准护理组加由术中高分数吸氧组成的EPO2CH束；定向液体疗法；正常体温;围手术期血糖控制；以及切口冲洗。这项研究是在荷兰的七家医院进行的。使用基于互联网的自动分配系统，患者每天以1:1的比例随机分配到每家医院，并具有可变的块大小。主要终点是意向治疗人群30天内SSI的发生率。本研究已在CCMO注册（NL-OMON50566）。在2016年3月1日至2020年3月26日期间，纳入了1777名患者。干预组869例（平均年龄63.1岁，女性467例，男性402例），对照组908例（平均年龄64.0岁，女性530例，男性378例）。干预组SSI发生率为18.4%(160/869)，对照组为18.9% (172/908)；意向治疗分析的相对危险度为0.98 (95% CI: 0.81-1.18)，按方案分析的相对危险度为0.91 （95% CI: 0.60-1.37）。发生严重不良事件的患者比例为33.3% (289/869)vs 33.5% (304/908), RR 0.99, 95% CI 0.87-1.23。解释：在高收入医疗环境中，如果将护理包与术前全身抗生素预防和基于酒精的手术皮肤准备等标准护理相结合，则不会降低手术部位感染的发生率。考虑到SSI的持续高风险，研究可能有助于降低这种风险的干预措施仍然迫切需要。资助：荷兰卫生研究与发展组织（ZonMW）由Innovatiefonds Zorgverzekeraars和Ethicon共同资助。

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A care bundle added to standard care versus standard care for the prevention of surgical site infections after abdominal surgery (EPO2CH trial): a randomised, open label, pragmatic, superiority multicentre trial

Background

Surgical site infections (SSI) are common. We selected five interventions from recent SSI prevention guidelines, to form the Enhanced PeriOperative Care and Health program (EPO₂CH), a perioperative care bundle. We aimed to investigate the effect of the EPO₂CH bundle on the incidence of SSI.

Methods

The EPO₂CH trial concerns an open label, pragmatic, randomised controlled parallel-group multicentre trial, in which we assigned patients, scheduled for elective abdominal surgery with incisions larger than five centimetres, to either standard care or standard care plus the EPO₂CH bundle consisting of intraoperative high fraction of inspired oxygen; Goal-Directed Fluid Therapy; normothermia; perioperative glucose control; and incisional wound irrigation. The study was conducted in seven hospitals in the Netherlands. Patients were randomised per hospital per day in a 1:1 ratio with variable block sizes using an internet-based automated assignment system. The primary outcome was the incidence of SSI within 30 days in the intention-to-treat population. This study is registered at CCMO register (NL-OMON50566).

Findings

Between March 1st, 2016, and March 26th, 2020, 1777 patients were included. The intervention group included 869 patients (mean age 63.1, 467 female and 402 male) versus 908 in the control group (mean age 64.0, 530 female and 378 male). The incidence of SSI was 18.4% (160/869) in the intervention and 18.9% (172/908) in the control group; relative risk 0.98 (95% CI: 0.81–1.18) in the intention-to-treat analysis and 0.91 (95% CI: 0.60–1.37) in the per-protocol analysis. The percentage of patients with a serious adverse event was 33.3% (289/869) versus 33.5% (304/908), RR 0.99, 95% CI 0.87–1.23.

Interpretation

In a high-income health care setting, a care bundle did not lead to a lower incidence of surgical site infections when added to standard care including preoperative systemic antibiotic prophylaxis and alcohol-based surgical skin preparation. Considering the persistent high risk of SSI, research into interventions that may help to reduce this risk remains urgently needed.

Funding

The Netherlands Organisation for Health Research and Development (ZonMW), and co-financed by Innovatiefonds Zorgverzekeraars, and Ethicon.

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.