Negative pressure wound therapy for managing the open abdomen in non-trauma patients

Cheng, Yao; Gong, Junhua; Liu, Zuojin; Gong, Jianping; Zeng, Zhong

doi:10.1002/14651858.cd013710

Cited by 3 publications

(3 citation statements)

References 49 publications

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“…A recent meta-analysis on the use of Damage Control in perforated acute colonic diverticulitis [48], found no RCTs and ultimately the conclusions reverted back to opinions, the weakest level of Evidence in the World Society of Emergency Surgery Consensus Guidelines [49,50]. In 2022, Cheng published a Cochrane Review on the use of negative pressure wound therapy for the non-trauma open abdomen and concluded that no recommendations could be made as there was no meaningful data [51]. Only one other RCT, conducted prior to 2006, has randomized 40 patients to a closed or open strategy, but the technique of OA management utilized then is inadequate according to current guidelines, as the NPPT apart from other aspects of OA management has evolved in technique and technology.…”

Section: Metanalyses and Randomized Controlled Studies Of The Open Ab...mentioning

confidence: 99%

The unrestricted global effort to complete the COOL trial

et al. 2023

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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 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. 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 recruitment has been lower than hoped but satisfactory, and the COOL steering committee and trial investigators intend with increased global support to continue enrollment until recruitment ensures a definitive answer. Discussion OA is mandated in many cases of SCIAS such as the risk of abdominal compartment syndrome associated with closure, or a planned second look as for example part of “damage control”; however, improved source control (locally and systemically) is the most uncertain indication for an OA. The COOL trial seeks to expand potential sites and proceed with the evaluation of NPPT agnostic to device, to properly examine the hypothesis that this treatment attenuates systemic damage and improves survival. This approach will not affect internal validity and should improve the external validity of any observed results of the intervention. Trial registration: National Institutes of Health (https://clinicaltrials.gov/ct2/show/NCT03163095).

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Section: Metanalyses and Randomized Controlled Studies Of The Open Ab...mentioning

confidence: 99%

The unrestricted global effort to complete the COOL trial

et al. 2023

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“…50 Yuksel Altinel reported no declarations. 51 Luz Adriana Hernandez Amin reported no declarations. 52 Jose Manuel Aranda reported no declarations.…”

Section: Discussionmentioning

confidence: 99%

“…A recent meta-analysis on the use of Damage Control in perforated acute colonic diverticulitis(48), found no RCTs and ultimately the conclusions reverted back to opinions, the weakest level of Evidence in the World Society of Emergency Surgery Consensus Guidelines (49,50). In 2022 Cheng published a Cochrane Review on the use of negative pressure wound therapy for the non-trauma open abdomen and concluded that no recommendations could be made as there was no meaningful data (51).…”

Section: Metanalyses and Randomized Controlled Studies Of The Open Ab...mentioning

confidence: 99%

The Unrestricted Global effort to complete the Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (COOL) Trial

Kirkpatrick

Coccolini

Tolonen

et al. 2023

Preprint

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· 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 patients allocated to the intervention (open) arm. In August 2022, the 3M/Acelity Corporation without consultation but within the terms of the contract cancelled 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 use of the OA with application of an NPPT dressing. Patients are eligible if they have free uncontained intra-peritoneal 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 recruitment has been lower than hoped but satisfactory, and the COOL steering committee and trial investigators intend with increased global support to continue enrollment until recruitment ensures a definitive answer. · Discussion: OA is mandated in many cases of SCIAS such as the risk of abdominal compartment syndrome associated with closure, or a planned second look as for example part of ‘damage control’, however improved source control (locally and systemically) is the most uncertain indication for an OA. The COOL-trial trial seeks to expand potential sites and proceed with evaluation of NPPT agnostic to device, to properly examine the hypothesis that this treatment attenuates systemic damage and improves survival. This approach will not affect internal validity and should improve the external validity of any observed results of the intervention. · Trial registration: National Institutes of Health (https://clinicaltrials.gov/ct2/show/NCT03163095).

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