Academic Journal
The unrestricted global effort to complete the COOL trial
| Τίτλος: | The unrestricted global effort to complete the COOL trial |
|---|---|
| Συγγραφείς: | Kirkpatrick A. W., Coccolini F., Tolonen M., Minor S., Catena F., Gois E., Doig C. J., Hill M. D., Ansaloni L., Chiarugi M., Tartaglia D., Ioannidis O., Sugrue M., Colak E., Hameed S. M., Lampela H., Agnoletti V., McKee J. L., Garraway N., Sartelli M., Ball C. G., Parry N. G., Voght K., Julien L., Kroeker J., Roberts D. J., Faris P., Tiruta C., Moore E. E., Ammons L. A., Anestiadou E., Bendinelli C., Bouliaris K., Carroll R., Ceresoli M., Favi F., Gurrado A., Rezende-Neto J., Isik A., Cremonini C., Strambi S., Koukoulis G., Testini M., Trpcic S., Pasculli A., Picariello E., Abu-Zidan F., Adeyeye A., Augustin G., Alconchel F., Altinel Y., Hernandez Amin L. A., Aranda-Narvaez J. M., Baraket O., Biffl W. L., Baiocchi G. L., Bonavina L., Brisinda G., Cardinali L., Celotti A., Chaouch M., Chiarello M., Costa G., de'Angelis N., De Manzini N., Delibegovic S., Di Saverio S., De Simone B., Dubuisson V., Fransvea P., Garulli G., Giordano A., Gomes C., Hayati F., Huang J., Ibrahim A. F., Huei T. J., Jailani R. F., Khan M., Luna A. P., Malbrain M. L. N. G., Marwah S., McBeth P., Mihailescu A., Morello A., Mulita F., Murzi V., Mohammad A. T., Parmar S., Pak A., Wong M. P. -K., Pantalone D., Podda M., Puccioni C., Rasa K., Ren J., Roscio F., Gonzalez-Sanchez A., Sganga G., Scheiterle M., Slavchev M., Smirnov D., Tosi L., Trivedi A., Vega J. A. G., Waledziak M., Xenaki S., Winter D., Wu X., Zakaria A. D., Zakaria Z. |
| Συνεισφορές: | Kirkpatrick, A, Coccolini, F, Tolonen, M, Minor, S, Catena, F, Gois, E, Doig, C, Hill, M, Ansaloni, L, Chiarugi, M, Tartaglia, D, Ioannidis, O, Sugrue, M, Colak, E, Hameed, S, Lampela, H, Agnoletti, V, Mckee, J, Garraway, N, Sartelli, M, Ball, C, Parry, N, Voght, K, Julien, L, Kroeker, J, Roberts, D, Faris, P, Tiruta, C, Moore, E, Ammons, L, Anestiadou, E, Bendinelli, C, Bouliaris, K, Carroll, R, Ceresoli, M, Favi, F, Gurrado, A, Rezende-Neto, J, Isik, A, Cremonini, C, Strambi, S, Koukoulis, G, Testini, M, Trpcic, S, Pasculli, A, Picariello, E, Abu-Zidan, F, Adeyeye, A, Augustin, G, Alconchel, F, Altinel, Y, Hernandez Amin, L, Aranda-Narvaez, J, Baraket, O, Biffl, W, Baiocchi, G, Bonavina, L, Brisinda, G, Cardinali, L, Celotti, A, Chaouch, M, Chiarello, M, Costa, G, De'Angelis, N, De Manzini, N, Delibegovic, S, Di Saverio, S, De Simone, B, Dubuisson, V, Fransvea, P, Garulli, G, Giordano, A, Gomes, C, Hayati, F, Huang, J, Ibrahim, A, Huei, T, Jailani, R, Khan, M, Luna, A, Malbrain, M, Marwah, S, Mcbeth, P, Mihailescu, A, Morello, A, Mulita, F, Murzi, V, Mohammad, A, Parmar, S, Pak, A, Wong, M, Pantalone, D, Podda, M, Puccioni, C, Rasa, K, Ren, J, Roscio, F, Gonzalez-Sanchez, A, Sganga, G, Scheiterle, M |
| Στοιχεία εκδότη: | BioMed Central Ltd GB |
| Έτος έκδοσης: | 2023 |
| Συλλογή: | Università degli Studi di Milano-Bicocca: BOA (Bicocca Open Archive) |
| Θεματικοί όροι: | Global health, Intraperitoneal sepsi, Laparotomy, Multiple organ dysfunction, Open abdomen, Peritoniti, Randomized controlled trial, Septic shock |
| Περιγραφή: | Background: 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 3M/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. Methods: The COOL trial is the largest prospective randomized controlled trial examining the random allocation of SCIAS patients intra-operatively to either formal closure of the fascia or the use of the OA with an application of an NPPT dressing. Patients are eligible if they have free uncontained intraperitoneal contamination and physiologic derangements exemplified by septic shock OR severely adverse predicted clinical outcomes. The primary outcome is intended to definitively inform global practice by conclusively evaluating 90-day survival. Initial ... |
| Τύπος εγγράφου: | article in journal/newspaper |
| Περιγραφή αρχείου: | ELETTRONICO |
| Γλώσσα: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/37170123; info:eu-repo/semantics/altIdentifier/wos/WOS:000992479600001; volume:18; issue:1; journal:WORLD JOURNAL OF EMERGENCY SURGERY; https://hdl.handle.net/10281/418863 |
| DOI: | 10.1186/s13017-023-00500-z |
| Διαθεσιμότητα: | https://hdl.handle.net/10281/418863 https://doi.org/10.1186/s13017-023-00500-z |
| Rights: | info:eu-repo/semantics/openAccess ; license:Creative Commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Αριθμός Καταχώρησης: | edsbas.EADF7632 |
| Βάση Δεδομένων: | BASE |
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