Hypochlorous acid testing studies: elective surgeries (Hypoclates:Elective)
Tobias Hoch Al Hessen, Niels Siegel, Mika P Nadvornik, Axel Kramer, Jonathan M Harnoss, Pascal Probst, Mohammed Al-Saeedi, Martin Loos, Christoph W Michalski, Julian C HarnossIntroduction
Surgical site infections (SSI) impose a substantial clinical and economic burden on healthcare systems, accounting for approximately 15% of nosocomial infections. While intraoperative lavage is predominantly performed with isotonic solutions, its efficacy in preventing SSI remains unproven. Hypochlorous acid (HOCl) has emerged as a promising antimicrobial agent due to its potent microbicidal properties and high biocompatibility. The primary objective of this study is to evaluate whether the systematic introduction of a standardised intraoperative lavage with HOCl reduces the incidence of SSI in patients undergoing elective visceral surgery compared with conventional irrigation with isotonic saline. It is hypothesised that the implementation of HOCl-based lavage will lead to a significant reduction in the composite rate of superficial, deep and organ/space SSIs during the immediate postoperative hospitalisation period.
Methods
This is a single-centre, prospective, sequential, quasi-experimental trial conducted at Heidelberg University Hospital. A prospective cohort of approximately 500 adult patients undergoing elective visceral surgery with HOCl-based lavage (Granudacyn) will be compared with a sequential retrospective control cohort of 500 patients treated with isotonic solution. The primary outcome is the incidence of SSI (superficial, deep or organ/space) according to Centres for Disease Control and Prevention criteria, assessed until hospital discharge or postoperative day 10 (±2 days). Secondary outcomes include length of stay in the intensive care unit and hospital, duration of antibiotic therapy and the Comprehensive Complication Index (CCI).
Ethics and dissemination
The study protocol has been approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-522/2025). Findings will be disseminated through peer-reviewed publications and presentations at international surgical congresses to inform clinical practice and future SSI prevention guidelines.
Trial registration number
DRKS00038635