Title {1} | Peritoneal antiseptic irrigation to prevent surgical site infection after laparotomy for hepatobiliary or gastrointestinal surgery (PAISI) |
Trial registration {2a and 2b}. | The study was registered in the German Clinical Trials Register DRKS on the 27.05.2022, Nr.: DRKS00028037 |
Protocol version {3} | Version 3.0, 11.05.2022 |
Funding {4} | The study is supported by a grant from the Investigator Initiated Studies Program of Mölnlycke Healthcare |
Author details {5a} |
Dr. med. Tara Mueller, Prof. Dr. med. Daniel Reim, Prof. Dr. med. Alexander Novotny and Univ.-Prof. Dr. med. Helmut Friess, Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich, Germany Dr. rer. nat. Victoria Kehl and Dr. rer. nat. Silvia Egert-Schwender, Münchner Studienzentrum, School of Medicine, Technical University of Munich, Germany |
Name and contact information for the trial sponsor {5b} |
In this study setting, investigating the effects of a routine medical procedure, there is no “trial sponsor”(according to German law). The study leadership consists of the principal initiating investigators: Dr. Tara Mueller and Prof. Daniel Reim Department of Surgery Klinikum rechts der Isar, Technical University of Munich Ismaningerstr. 22 81675 Munich, Germany Email: tara.mueller@tum.de; daniel.reim@tum.de |
Role of sponsor {5c} | In this study setting there is no “trial sponsor” as outlined under {5b}. The study leadership has ultimate authority over study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. |