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.