Clinical Trial

Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics

Study acronym: AbClo-Resp
Recruiting
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Record status
This record was last updated April 22, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an "open abdomen". To limit the risk of further widening of their wounds, surgeons can use AbClo, which is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims: * To assess whether the abdominal binding device causes changes in the pressure compressing the lungs, the lung volume, and the function of the lungs. * To assess whether adjusting the breathing machine can mitigate such negative changes. Participants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-26.
Trial Details
NCT Number NCT07154589
Lead Sponsor Unity Health Toronto
Conditions Open Abdomen, Mechanical Ventilation
Enrollment 18 participants
Start Date 2025-06-10
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-22