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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

18 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Adult patients aged 18 years or older
• Patients admitted to an ICU
• Patients with postoperative abdominal surgery with open abdomen
• Patients treated with AbClo device
• Patients intubated and mechanically ventilated
• Patients treated with intravenous sedation with a sedation-agitation scale score of 1-3

Exclusion Criteria:

• Transient criteria: Patients with severe hemodynamic instability, defined systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use
• Transient criteria: Patients with severe bleeding diathesis, defined as the latest platelet count less than 20 · 109/L, or the latest INR higher than 2.0
• Patients with concurrent injuries to upper gastrointestinal tract that would preclude esophageal balloon insertion
• Patients with bronchopleural fistula
• Patients with measured and uncontrolled increased intracranial pressure

Study population

Adult patients admitted the ICU with open abdomen treated with AbClo device, and undergoing mechanical ventilation

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Unity Health Toronto

Study start

Jun 10, 2025 Actual

Primary completion

2027-06 Estimated

Study completion

2027-06 Estimated

First posted

Sep 4, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts