Study design
intraabdominal infectious
HBP, POSTOPERATIVE COMPLICATIONS
This is a single-centre, open-label, parallel, pragmatic, superiority randomized clinical trial. Patients were recruited from the Hepatobiliary and Pancreatic (HBP) surgery unit in a referral tertiary Hospital. Patients were eligible if they were planned to undergo elective HBP surgery, irrespective to the surgical indication, and they agreed to participate voluntarily in the study and therefore signed the provided written informed consent. All patients accepted to comply with the study protocol postoperative follow-up in outpatients’ clinics. There were no restrictions regarding surgical procedures. Exclusion criteria included: urgent or emergent surgery, class IV wounds according to the CDC classification (i.e. dirty or infected surgical site)15 and the presence of an active uncontrolled intraabdominal infectious foci prior to the intervention. Additional exclusion criteria were intraoperative uncontrolled faecal contamination of the surgical site and patients requiring reintervention due to major postoperative complications during follow-up, considering the potential confounding factor with the primary endpoint. Furthermore, all patients not complying with the specific study perioperative SSI prevention bundle or if they refused to participate, either verbal or in writing, were also excluded.All eligible patients provided written informed consent before undergoing study related procedures. The study was approved by the local Ethics Committee for Clinical Research of Donostia University Hospital and was conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013). This trial was designed and reported according to the CONSORT guidelines16 and was prospectively registered at ISRCTN registry, with the number ISRCTN 37315612 on the 14/01/2020.