PREVE-NAT: Prevention of intraabdominal abscesses requiring intervention after laparotomy for acute peritonitis through intraoperative peritoneal lavage with Sodium hypochlorite/hypochlorous acid (NaOCl/HOCl) - a pilot RCT

• Applicant: Dr. Emmanouil Tzatzarakis
• Subject Area: General and Visceral Surgery ; Clinical Infectiology and Tropical Medicine ; Medical Microbiology and Mycology, Hygiene, Molecular Infection Biology
• Term: since 2024
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 519228500

Intraperitoneal Abscesses are a frequent complication after surgery for acute peritonitis and are often associated with further interventions and an increased morbidity for the patient. The standard therapy to date consists of peritoneal lavage with ringer's or sodium chloride solution, after the source of the infection is eradicated, which is in itself hardly efficient against infections. Sodium hypochlorite/hypochlorous acid (NaOCl/HOCl) is an already established solution for the treatment of chronic wounds, which is further licensed for intraperitoneal application. Through its physiologic mechanism of action and its rapid reverse reaction to sodium chloride, it represents a potential low-risk alternative for the peritoneal lavage. Its safety and tolerability have already been demonstrated experimentally, as well as in small case series. Its efficacy against problematic germs, such as MRSA or pseudomonas, as well as against biofilms, has also been shown in some studies. The available data regarding the intraperitoneal application is thus positive, however still sparse. Aim of this study is to compare the application of additional abdominal lavage with NaOCl/HOCl versus the current standard therapy with solely ringer's solution regarding the occurrence of post-operative intraabdominal abscesses, in need of intervention. For that purpose, a total of 90 patients with an intraoperatively diagnosed acute peritonitis will be enrolled and randomised in two groups 1:1. The control group will then receive the standard therapy, whereas the intervention group will receive an additional intraperitoneal instillation of 1000ml NaOCl/HOCl at the end of the surgery, which will be let out after 15 Minutes through the established surgical drainage catheters. Primary endpoint is the incidence of post-operative, intraabdominal abscesses in need of intervention. Key secondary endpoints are morbidity, mortality, length of hospitalization and time to first bowel movement among others. The study in question is a pilot study, which could serve as the foundation for a larger, multi-centre study in the future.

• DFG Programme: Research Grants
• Co-Investigators: Privatdozent Dr. Florian Herrle; Professor Dr. Christoph Reißfelder