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

PREVE-NAT：通过术中次氯酸钠/次氯酸 (NaOCl/HOCl) 腹腔灌洗预防急性腹膜炎剖腹术后需要干预的腹内脓肿 - 一项试点随机对照试验

• 批准号: 519228500
• 负责人: Dr. Emmanouil Tzatzarakis
• 金额: --
• 依托单位: Chirurgische Klinik
• 依托单位国家: 德国
• 项目类别: Research Grants
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/519228500?language=en
• 关键词: PREVE; NAT; Prevention; intraabdominal; abscesses

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.

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增加患者的发病率有关。到目前为止，标准的治疗方法是在根除感染源后，用林格氏或氯化钠溶液进行腹膜冲洗，这本身对感染几乎没有效果。次氯酸钠/次氯酸(NaOCl/HOCl)是一种已经确定的用于治疗慢性伤口的溶液，它还被批准用于腹膜内应用。通过其生理作用机制和对氯化钠的快速逆转反应，它是一种潜在的低风险的腹膜灌洗替代品。它的安全性和耐受性已经在实验和小病例系列中得到了证明。它对有问题的细菌，如MRSA或假单胞菌，以及对生物被膜的有效性也在一些研究中显示出来。因此，关于腹膜腔内应用的现有数据是积极的，尽管仍然很稀少。本研究的目的是比较在术后需要干预的情况下，应用NaOCl/HOCl和目前仅使用林格氏液的标准疗法的腹部脓肿发生率。为此，共有90名手术中诊断为急性腹膜炎的患者将被纳入并随机分为两组，1：1。对照组将接受标准治疗，而干预组将在手术结束时额外接受1000毫升NaOCl/HOCl的腹膜内滴注，15分钟后通过已建立的外科引流导管将其排出。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。这项研究是一项先导性研究，可作为未来更大规模、多中心研究的基础。