AWK, LA, both FCs, both MSs, MT, JLM, CD, and MH, as well as the General membership of the Abdominal Compartment Society and the World Society of Emergency Surgery conceptualized the study.
AWK drafted the initial manuscript.
CD, MH, AG, JLM, and DJR extensively re-wrote the initial manuscript.
All authors read and approved the final manuscript.
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 3M/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.
Ethics : The 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 Publication: Not Applicable.
Availability of Data and Materials: All results and data from the COOL trial will be available from Dr Andrew Kirkpatrick ([email protected]) on reasonable request, as well as from the Study Website (www.coolstudy.ca).
1Andrew W Kirkpatrick serves as the PI of the COOL trial, as a member of the Canadian Forces Medical Services and has consulted for the 3m/Acelity Corporation, Zoll Medical, Innovative Trauma Care, CSL Behring, and the Statesman’s Group.
2Federico Coccolini reported no declarations.
3Matti Tolonen reported no declarations.
4Samuel Minor reported receiving research support and speaking honoraria from COOK Biotech
5 Emanual Gois reported no declarartions.
6Fausto Catena reported no declarations.
7Christopher J Doig reported no declarations.
8Michael D Hill reported no declarations.
9Luca Ansaloni reported no declarations.
10Massimo Chiurgi reported no declarations.
11Dario Tartaglia reported no declarations.
12Orestis Ioannidis reported no declarations.
13Michael Sugrue reported consultancy for 3M/Acelity and Novus Scientific
14Elif Colak reported no declarations.
15S Morad Hameed reported being the Founder of T6 Health Systems.
16Hanna Lampela reported no declarations.
17Vanni Agnoletti reported no declarations.
18Jessica 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.
19Naisan Garraway reported no declarations.
20Massimo Sartelli reported no declarations.
21Chad G Ball reported no declarations.
22Neil G Parry reported being medical advisor for Front Line Medical Technologies – Cobra REBOA
23Kelly Voght reported no declarations.
24Lisa Julien reported no declarations.
25Jenna Kroeker reported no declarations.
26Derek J Roberts reported no declarations.
27Peter Faris reported no declarations.
28Corina Tiruta reported no declarations.
29Ernest E Moore reported no declarations.
30Lee Ann Ammons reported no declarations.
31Elissavet Anestiadou reported no declarations.
32Cino Bendinelli reported no declarations.
33Konstantinos Bouliaris reported no declarations.
34Rosemarry Carroll reported no declarations.
35Marco Ceresoli reported no declarations.
36Francesco Favi reported no declarations.
37Angel Gurrado reported no declarations.
38Joao Rezende-Neto reported no declarations.
39Arda Isik reported no declarations
40Camilla Cremonini reported no declarations.
41Silivia Strambi reported no declarations.
42Georgios Konstantoudakis reported no declarations.
43Mario Testini reported no declarations.
44Sandy Trpcic reported no declarations.
45Alessandro Pasculli reported no declarations.
46Erika Picariello reported no declarations.
47Ademola Adeyeye reported no declarations.
48Goran Augustin reported no declarations.
49Felipe Alconchel reported no declarations.
50Yuksel Altinel reported no declarations.
51Luz Adriana Hernandez Amin reported no declarations.
52Jose Manuel Aranda reported no declarations.
53Oussama Baraket reported no declarations.
54Walter L Biffl reported no declarations.
55Luca Baiocchi reported no declarations.
56Luigi Bonavina reported no declarations.
57Giuseppe Brisinda reported no declarations.
58Luca Cardinali reported no declarations.
59Andrea Celotti reported no declarations.
60Mohamed Chaouch reported no declarations.
61Maria Michela Chiarello reported no declarations.
62Gianluca Costa reported no declarations.
63Nicola de’Angelis reported no declarations.
64Nicolo de Manzini reported no declarations.
65Samir Delibegovic reported no declarations.
66Salomone Di Saverio reported no declarations.
67Belinda De Simone reported no declarations.
68Dr Vincent Dubuisson received grants from 3M-Acelity in 2021 for a conference about how to manage an OA, at the congress of the French Association of Surgery
69Pietro Fransvea reported no declarations.
70Luca Garulli reported no declarations.
71Alessio Giordano reported no declarations.
72Carlos Gomes reported no declarations.
73Firdaus Hiyati reported no declarations.
74Jinjian Huang reported no declarations.
75Aini Fahriza Ibrahim reported no declarations.
76Tan Jih Huei reported no declarations.
77Ruhi Fadzlyana Binti Jailan reported no declarations.
78Mansour Khan reported no declarations.
79Alfonso Palmieri Luna reported no declarations.
80 Manu Malbrain reported he is co-founder, past-President and current Treasurer of WSACS (The Abdominal Compartment Society, http://www.wsacs.org). He is 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.
81Sanjay Marwah reported no declarations.
82Paul McBeth reported no declarations.
83Andrei Mihailescu reported no declarations.
84Alessia Morello reported no declarations.
85Francesk Mulita reported no declarations.
86Valentia Murzi reported no declarations.
87Ahmad Tarmizi Mohammad reported no declarations.
88Simran Parmar reported no declarations.
89Ajay Pal reported no declarations.
90Michael Pak-Kai Wong reported no declarations.
91Desire Pantalone reported no declarations.
99Simran Parmar reported no declarations.
92Mauro Podda reported no declarations.
93Caterina Puccioni reported no declarations.
94Kemal Rasa reported no declarations.
95Jianen Ren reported no declarations.
96Francesco Roscio reported no declarations.
97Antonio Gonzalez-Sanchez reported no declarations.
98Gabriele Sganga reported no declarations.
99Maximilian Leonardo Philip Federico Scheiterlem reported no declarations.
100Mihail Slavchev reported no declarations.
101Dmitry Smirnov reported no declarations.
102Lorenzo Tosi reported no declarations.
103Anand Trivedi reported no declarations.
104Dr Jaime Andres Gonzalez Vega reported no declarations.
105Maciej Waledziak reported no declarations.
106Sofia Xenaki reported no declarations.
107Desmond Winter reported no declarations.
108Xiuwen Wu reported no declarations.
109Andeen Zakaria reported no declarations.
110Zaidia Zakaria reported no declarations.
Acknowledgments: Not Applicable