HYPOChLorous Acid TEsting Studies in secondary peritonitis (Hypoclates:Peritonitis): extended hypochlorous acid versus isotonic lavage for the prevention of surgical site infections in secondary peritonitis in Germany - protocol for a sequential, quasi-experimental cohort study.

内容摘要

Surgical site infections (SSIs) impose a significant clinical and economic burden on the healthcare systems. To date, traditional preventive strategies have frequently failed to demonstrate definitive efficacy. Hypochlorous acid (HOCl) has emerged as a compelling antimicrobial alternative, characterised by potent microbicidal properties and excellent biocompatibility. Hypoclates:Peritonitis investigates the clinical impact of an HOCl-based lavage strategy in patients undergoing surgical treatment for secondary peritonitis. The trial evaluates the primary endpoint of postoperative SSI incidence up to day 10 (±2 days), hypothesising that the antimicrobial and biocompatible properties of HOCl significantly lower infection rates compared with standard isotonic lavage. Using a sequential, quasi-experimental design, this mono-centric study assesses the clinical impact of adopting an intensified, multi-day HOCl-lavage protocol (Granudacyn) for patients with secondary peritonitis. We will compare a prospective intervention group (n≈100) against a preceding cohort of equal size that received standard isotonic irrigation. The primary endpoint is defined as the frequency of SSIs-inclusive of superficial, deep and organ/space infections according to Centers for Disease Control and Prevention criteria-monitored through hospital discharge or up to postoperative day 10 (±2 days). Secondary evaluative measures include the length of intensive care unit and total hospital stay, the duration of postoperative antibiotic therapy and the cumulative morbidity burden as calculated by the Comprehensive Complication Index. Ethical clearance for this trial was provided by the Institutional Review Board of the Medical Faculty of Heidelberg University (S-523/2025). To facilitate knowledge transfer and evidence-based practice, the study results will be presented at international scientific meetings and published in peer-reviewed journals, thereby contributing to the refinement of SSI prevention protocols in emergency visceral surgery. German Clinical Trials Register (DRKS), DRKS00038630.