Staff View: The unrestricted global efort to complete the COOL trial

The unrestricted global efort to complete the COOL trial

Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple orga...

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Main Authors:	Andrew, W. Kirkpatrick, Federico, Coccolini, Matti, Tolonen, Samuel, Minor, Fausto, Catena, Emanuel, Gois Jr., Christopher, J. Doig, Michael, D. Hill, Luca, Ansaloni, Massimo, Chiarugi, Dario, Tartaglia, Orestis, loannidis, Michael, Sugrue, Elif, Colak, S. Morad, Hameed, Hanna, Lampela, Vanni, Agnoletti, Jessica, L. McKee, Naisan, Garraway, Aini Fariza, Ibrahim
Format:	Article
Language:	English
Published:	BioMed Central Ltd. 2023
Subjects:	R Medicine (General)
Online Access:	http://ir.unimas.my/id/eprint/44037/1/The%20unrestricted.pdf http://ir.unimas.my/id/eprint/44037/ https://wjes.biomedcentral.com/articles/10.1186/s13017-023-00500-z https://doi.org/10.1186/s13017-023-00500-z
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id	my.unimas.ir.44037
record_format	eprints
spelling	my.unimas.ir.440372024-01-10T02:16:29Z http://ir.unimas.my/id/eprint/44037/ The unrestricted global efort to complete the COOL trial Andrew, W. Kirkpatrick Federico, Coccolini Matti, Tolonen Samuel, Minor Fausto, Catena Emanuel, Gois Jr. Christopher, J. Doig Michael, D. Hill Luca, Ansaloni Massimo, Chiarugi Dario, Tartaglia Orestis, loannidis Michael, Sugrue Elif, Colak S. Morad, Hameed Hanna, Lampela Vanni, Agnoletti Jessica, L. McKee Naisan, Garraway Aini Fariza, Ibrahim R Medicine (General) Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. A further therapeutic option may be open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) to remove inflammatory ascites and attenuate the systemic damage from SCIAS, although there are definite risks of leaving the abdomen open whenever it might possibly be closed. This potential therapeutic paradigm is the rationale being assessed in the Closed Or Open after Laparotomy (COOL trial) (https://clinicaltrials.gov/ct2/show/NCT03163095). Initially, the COOL trial received Industry sponsorship; however, this funding mandated the use of a specific trademarked and expensive NPPT device in half of the patients allocated to the intervention (open) arm. In August 2022, the 3 M/Acelity Corporation without consultation but within the terms of the contract canceled the financial support of the trial. Although creating financial difficulty, there is now no restriction on specific NPPT devices and removing a cost-prohibitive intervention creates an opportunity to expand the COOL trial to a truly global basis. This document describes the evolution of the COOL trial, with a focus on future opportunities for global growth of the study. BioMed Central Ltd. 2023 Article PeerReviewed text en http://ir.unimas.my/id/eprint/44037/1/The%20unrestricted.pdf Andrew, W. Kirkpatrick and Federico, Coccolini and Matti, Tolonen and Samuel, Minor and Fausto, Catena and Emanuel, Gois Jr. and Christopher, J. Doig and Michael, D. Hill and Luca, Ansaloni and Massimo, Chiarugi and Dario, Tartaglia and Orestis, loannidis and Michael, Sugrue and Elif, Colak and S. Morad, Hameed and Hanna, Lampela and Vanni, Agnoletti and Jessica, L. McKee and Naisan, Garraway and Aini Fariza, Ibrahim (2023) The unrestricted global efort to complete the COOL trial. World Journal of Emergency Surgery, 18 (33). pp. 1-18. ISSN 1749-7922 https://wjes.biomedcentral.com/articles/10.1186/s13017-023-00500-z https://doi.org/10.1186/s13017-023-00500-z
institution	Universiti Malaysia Sarawak
building	Centre for Academic Information Services (CAIS)
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Malaysia Sarawak
content_source	UNIMAS Institutional Repository
url_provider	http://ir.unimas.my/
language	English
topic	R Medicine (General)
spellingShingle	R Medicine (General) Andrew, W. Kirkpatrick Federico, Coccolini Matti, Tolonen Samuel, Minor Fausto, Catena Emanuel, Gois Jr. Christopher, J. Doig Michael, D. Hill Luca, Ansaloni Massimo, Chiarugi Dario, Tartaglia Orestis, loannidis Michael, Sugrue Elif, Colak S. Morad, Hameed Hanna, Lampela Vanni, Agnoletti Jessica, L. McKee Naisan, Garraway Aini Fariza, Ibrahim The unrestricted global efort to complete the COOL trial
description	Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. A further therapeutic option may be open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) to remove inflammatory ascites and attenuate the systemic damage from SCIAS, although there are definite risks of leaving the abdomen open whenever it might possibly be closed. This potential therapeutic paradigm is the rationale being assessed in the Closed Or Open after Laparotomy (COOL trial) (https://clinicaltrials.gov/ct2/show/NCT03163095). Initially, the COOL trial received Industry sponsorship; however, this funding mandated the use of a specific trademarked and expensive NPPT device in half of the patients allocated to the intervention (open) arm. In August 2022, the 3 M/Acelity Corporation without consultation but within the terms of the contract canceled the financial support of the trial. Although creating financial difficulty, there is now no restriction on specific NPPT devices and removing a cost-prohibitive intervention creates an opportunity to expand the COOL trial to a truly global basis. This document describes the evolution of the COOL trial, with a focus on future opportunities for global growth of the study.
format	Article
author	Andrew, W. Kirkpatrick Federico, Coccolini Matti, Tolonen Samuel, Minor Fausto, Catena Emanuel, Gois Jr. Christopher, J. Doig Michael, D. Hill Luca, Ansaloni Massimo, Chiarugi Dario, Tartaglia Orestis, loannidis Michael, Sugrue Elif, Colak S. Morad, Hameed Hanna, Lampela Vanni, Agnoletti Jessica, L. McKee Naisan, Garraway Aini Fariza, Ibrahim
author_facet	Andrew, W. Kirkpatrick Federico, Coccolini Matti, Tolonen Samuel, Minor Fausto, Catena Emanuel, Gois Jr. Christopher, J. Doig Michael, D. Hill Luca, Ansaloni Massimo, Chiarugi Dario, Tartaglia Orestis, loannidis Michael, Sugrue Elif, Colak S. Morad, Hameed Hanna, Lampela Vanni, Agnoletti Jessica, L. McKee Naisan, Garraway Aini Fariza, Ibrahim
author_sort	Andrew, W. Kirkpatrick
title	The unrestricted global efort to complete the COOL trial
title_short	The unrestricted global efort to complete the COOL trial
title_full	The unrestricted global efort to complete the COOL trial
title_fullStr	The unrestricted global efort to complete the COOL trial
title_full_unstemmed	The unrestricted global efort to complete the COOL trial
title_sort	unrestricted global efort to complete the cool trial
publisher	BioMed Central Ltd.
publishDate	2023
url	http://ir.unimas.my/id/eprint/44037/1/The%20unrestricted.pdf http://ir.unimas.my/id/eprint/44037/ https://wjes.biomedcentral.com/articles/10.1186/s13017-023-00500-z https://doi.org/10.1186/s13017-023-00500-z
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score	13.211869

The unrestricted global efort to complete the COOL trial

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