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

腹膜内脓肿是急性腹膜炎手术后常见的并发症，通常与进一步干预和患者发病率增加有关。迄今为止的标准治疗方法是在传染源被根除后，用林格氏液或氯化钠溶液进行腹腔灌洗，这本身对感染几乎没有效果。次氯酸钠/次氯酸（NaOCl/HOCl）是一种已经建立的治疗慢性伤口的解决方案，它进一步被许可用于腹腔内应用。通过其生理作用机制和对氯化钠的快速逆反应，它代表了一种潜在的低风险的腹腔灌洗替代品。它的安全性和耐受性已经在实验和小案例系列中得到证明。在一些研究中，它对MRSA或假单胞菌等有问题的细菌以及生物膜的功效也得到了证明。因此，关于腹腔内应用的现有数据是积极的，但仍然很少。本研究的目的是比较NaOCl/HOCl加洗腹与目前标准的单纯林格液治疗对术后需要干预的腹腔内脓肿发生的影响。为此，共有90例术中诊断为急性腹膜炎的患者将被纳入研究，并随机分为两组。对照组将接受标准治疗，干预组将在手术结束时额外腹腔内滴注1000ml NaOCl/HOCl， 15分钟后通过建立的手术引管排出。主要终点是术后需要干预的腹内脓肿的发生率。关键的次要终点是发病率、死亡率、住院时间和首次排便时间等。这项研究是一项初步研究，可以作为未来更大规模、多中心研究的基础。

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.