The unrestricted global effort to complete the COOL trial.

"Declarations Ethics approval and consent to participateThe COOL trial has been ethically approved at the lead and pilot center by the Conjoint Health Research Ethics Board (CHREB) of the University of Calgary (REB16-1588). The study has also been registered with the National Institutes of Health (ClinicalTrials.gov Identifier: NCT03163095). Consent for PublicationNot Applicable. Competing interestsAndrew W Kirkpatrick serves as the PI of the COOL trial, as a member of the Canadian Forces Medical Services, and has consulted for the 3 m/Acelity Corporation, Zoll Medical, Innovative Trauma Care, CSL Behring, and the Statesman’s Group. Federico Coccolini, Matti Tolonen reported no declarations. Samuel Minor reported receiving research support and speaking honoraria from COOK Biotech. Emanuel Gois Jr. reported no declarations. Fausto Catena, Christopher J Doig, Michael D Hill, Luca Ansaloni, Massimo Chiurgi, Dario Tartaglia, Orestis Ioannidis reported no declarations. Michael Sugrue reported consultancy for 3 M/Acelity and Novus Scientific. Elif Colak: reported no declarations. S Morad Hameed reported being the Founder of T6 Health Systems. Hanna Lampela, Vanni Agnoletti reported no declarations. Jessica L McKee reported consultancies with the Aceso, Innovative Trauma Care, Andrew W Kirkpatrick, and Zoll Corporations, as well as consulting with the Geneva Foundation and South Trail Psychology. Naisan Garraway, Massimo Sartelli, Chad G Ball reported no declarations. Neil G Parry reported being a medical advisor for Front Line Medical Technologies – Cobra REBOA. Kelly Voght, Lisa Julien, Jenna Kroeker reported no declarations. Derek J Roberts, Peter Faris, Corina Tiruta, Ernest E Moore, Lee Ann Ammons, Elissavet Anestiadou, Cino Bendinelli, Konstantinos Bouliaris, Rosemarry Carroll, Marco Ceresoli, Francesco Favi, Angela Gurrado, Joao Rezende-Neto, Arda Isik, Camilla Cremonini, Silivia Strambi, Georgios Konstantoudakis, Mario Testini, Sandy Trpcic, Alessandro Pasculli, Erika Picariello, Fikri Abu-Zidan, Ademola Adeyeye, Goran Augustin, Felipe Alconchel, Yuksel Altinel, Luz Adriana Hernandez Amin, José Manuel-Narváez, Oussama Baraket, Walter L Biffl, Gian Luca Baiocchi, Luigi Bonavina, Giuseppe Brisinda, Luca Cardinali, Andrea Celotti, Mohamed Chaouch, Maria Michela Chiarello, Gianluca Costa, Nicola de’Angelis, Nicolo de Manzini, Samir Delibegovic, Salomone Di Saverio, Belinda De Simone reported no declarations. Dr Vincent Dubuisson received speaking honoraria from 3 M-Acelity in 2021 for a conference about how to manage an OA, at the congress of the French Association of Surgery. Pietro Fransvea, Luca Garulli, Alessio Giordano, Carlos Gomes, Firdaus Hayati, Jinjian Huang, Aini Fahriza Ibrahim, Tan Jih Huei, Ruhi Fadzlyana Jailani, Mansoor Khan, Alfonso Palmieri Luna reported no declarations. Manu L.N.G. Malbrain reported he is co-founder, past-President and current Treasurer of WSACS (The Abdominal Compartment Society, http://www.wsacs.org). He is a member of the medical advisory Board of Pulsion Medical Systems (part of Getinge group), Serenno Medical, Potrero Medical, Sentinel Medical and Baxter. He consults for BBraun, Becton Dickinson, ConvaTec, Spiegelberg, and Holtech Medical and received speaker's fees from PeerVoice. He holds stock options for Serenno and Potrero. Sanjay Marwah, Paul McBeth, Andrei Mihailescu, Alessia Morello, Francesk Mulita, Valentia Murzi, Ahmad Tarmizi Mohammad, Simran Parmar, Ajay Pal, Michael Pak-Kai Wong, Desire Pantalone, Mauro Podda, Caterina Puccioni, Kemal Rasa, Jianan Ren, Francesco Roscio, Antonio Gonzalez-Sanchez, Gabriele Sganga, Maximilian Scheiterle, Mihail Slavchev, Dmitry Smirnov, Lorenzo Tosi, Anand Trivedi, Jaime Andres Gonzalez Vega, Maciej Waledziak, Sofia Xenaki, Desmond Winter, Xiuwen Wu, Andee Dzulkarnean Zakaria reported no declarations. Competing interests Andrew W Kirkpatrick serves as the PI of the COOL trial, as a member of the Canadian Forces Medical Services, and has consulted for the 3 m/Acelity Corporation, Zoll Medical, Innovative Trauma Care, CSL Behring, and the Statesman’s Group. Federico Coccolini, Matti Tolonen reported no declarations. Samuel Minor reported receiving research support and speaking honoraria from COOK Biotech. Emanuel Gois Jr. reported no declarations. Fausto Catena, Christopher J Doig, Michael D Hill, Luca Ansaloni, Massimo Chiurgi, Dario Tartaglia, Orestis Ioannidis reported no declarations. Michael Sugrue reported consultancy for 3 M/Acelity and Novus Scientific. Elif Colak: reported no declarations. S Morad Hameed reported being the Founder of T6 Health Systems. Hanna Lampela, Vanni Agnoletti reported no declarations. Jessica L McKee reported consultancies with the Aceso, Innovative Trauma Care, Andrew W Kirkpatrick, and Zoll Corporations, as well as consulting with the Geneva Foundation and South Trail Psychology. Naisan Garraway, Massimo Sartelli, Chad G Ball reported no declarations. Neil G Parry reported being a medical advisor for Front Line Medical Technologies – Cobra REBOA. Kelly Voght, Lisa Julien, Jenna Kroeker reported no declarations. Derek J Roberts, Peter Faris, Corina Tiruta, Ernest E Moore, Lee Ann Ammons, Elissavet Anestiadou, Cino Bendinelli, Konstantinos Bouliaris, Rosemarry Carroll, Marco Ceresoli, Francesco Favi, Angela Gurrado, Joao Rezende-Neto, Arda Isik, Camilla Cremonini, Silivia Strambi, Georgios Konstantoudakis, Mario Testini, Sandy Trpcic, Alessandro Pasculli, Erika Picariello, Fikri Abu-Zidan, Ademola Adeyeye, Goran Augustin, Felipe Alconchel, Yuksel Altinel, Luz Adriana Hernandez Amin, José Manuel-Narváez, Oussama Baraket, Walter L Biffl, Gian Luca Baiocchi, Luigi Bonavina, Giuseppe Brisinda, Luca Cardinali, Andrea Celotti, Mohamed Chaouch, Maria Michela Chiarello, Gianluca Costa, Nicola de’Angelis, Nicolo de Manzini, Samir Delibegovic, Salomone Di Saverio, Belinda De Simone reported no declarations. Dr Vincent Dubuisson received speaking honoraria from 3 M-Acelity in 2021 for a conference about how to manage an OA, at the congress of the French Association of Surgery. Pietro Fransvea, Luca Garulli, Alessio Giordano, Carlos Gomes, Firdaus Hayati, Jinjian Huang, Aini Fahriza Ibrahim, Tan Jih Huei, Ruhi Fadzlyana Jailani, Mansoor Khan, Alfonso Palmieri Luna reported no declarations. Manu L.N.G. Malbrain reported he is co-founder, past-President and current Treasurer of WSACS (The Abdominal Compartment Society, http://www.wsacs.org). He is a member of the medical advisory Board of Pulsion Medical Systems (part of Getinge group), Serenno Medical, Potrero Medical, Sentinel Medical and Baxter. He consults for BBraun, Becton Dickinson, ConvaTec, Spiegelberg, and Holtech Medical and received speaker's fees from PeerVoice. He holds stock options for Serenno and Potrero. Sanjay Marwah, Paul McBeth, Andrei Mihailescu, Alessia Morello, Francesk Mulita, Valentia Murzi, Ahmad Tarmizi Mohammad, Simran Parmar, Ajay Pal, Michael Pak-Kai Wong, Desire Pantalone, Mauro Podda, Caterina Puccioni, Kemal Rasa, Jianan Ren, Francesco Roscio, Antonio Gonzalez-Sanchez, Gabriele Sganga, Maximilian Scheiterle, Mihail Slavchev, Dmitry Smirnov, Lorenzo Tosi, Anand Trivedi, Jaime Andres Gonzalez Vega, Maciej Waledziak, Sofia Xenaki, Desmond Winter, Xiuwen Wu, Andee Dzulkarnean Zakaria reported no declarations."

"Funding No funding was received for the conduct of this analysis or the preparation of this manuscript. The COOL Investigators as an entity were supported to conduct a Protocol Development Meeting in Parma Italy on November 26, 2017, through an unrestricted grant from the Acelity Corporation in which Inclusion Criteria for Closed Or Open after Laparotomy (COOL) for Source Control in Severe Complicated Intra-Abdominal Sepsis (https://clinicaltrials.gov/ct2/show/NCT03163095) trial was discussed. The 3 M/Acelity Corporation provided limited financial support for the COOL trial under contract 032519–000/2050 until unilateral cancelation on August 19, 2022. The COOL trial has also received unrestricted support from the Abdominal Compartment Society and the Andrew W Kirkpatrick Professional Corporation."

"Trial registration : National Institutes of Health ( https://clinicaltrials.gov/ct2/show/NCT03163095 )."