RecruitingOBSERVATIONAL

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

After major tummy surgery, some patients have an 'open abdomen'. To help close the wound and keep the tummy muscles together, doctors use a device called AbClo. This study investigates how the AbClo device, which gently presses on the tummy, affects breathing. Researchers want to see if it changes the pressure on the lungs, how much air the lungs can hold, and how well they work. They also want to find out if changes to the breathing machine can help if the AbClo device causes any breathing difficulties. Patients will already be using the AbClo device when they join the study, and measurements will be taken at different times.

At a glance

Status

Recruiting

Sponsor

Unity Health Toronto

Enrolment target

Start

10 Jun 2025

Estimated completion

01 Jun 2026

Open Abdomen Mechanical Ventilation

What is this study about?

When someone has a big operation on their tummy, sometimes the wound needs to stay open for a while to help with healing. This is called an 'open abdomen'. To help bring the edges of the wound together and stop it from getting bigger, doctors might use a device called AbClo. Think of it like a gentle belt that keeps the tummy muscles (called fascia) close to each other. This can help the tummy heal better.

However, because this device gently presses on the tummy, it might also press on the lungs, which are nearby. This study wants to find out if this pressure affects how well the lungs work. Specifically, doctors will be looking at things like the pressure inside the lungs, how much air the lungs can hold, and how well the lungs can get oxygen into the blood. Understanding these effects is important to make sure patients are as comfortable and safe as possible.

The study also aims to see if adjusting the special breathing machines (called ventilators) that some patients are on can help if the AbClo device causes any problems with breathing. By making small changes to the breathing machine, doctors hope to balance its support with the use of the AbClo device. This research is about improving care for patients with an open abdomen and making sure their breathing is not negatively affected.

Key takeaways

The study looks at how a device called AbClo affects breathing and lung function.
It aims to see if breathing machine settings can help manage any changes.
You would already be using the AbClo device and be on a breathing machine.
No new treatments or medications are given; it involves extra measurements.
This research helps improve care for patients with an 'open abdomen'.

Who may be eligible?

This study is for adults aged 18 or older who are currently in intensive care. You would need to have had a recent tummy operation where your abdomen (tummy) has been left open, and you must already be using the AbClo device. Participants will also be connected to a breathing machine and receiving medicine to help them relax (sedation).

There are certain situations where you wouldn't be able to join the study. For example, if your blood pressure is very unstable, or if you have a serious problem with bleeding. Issues like a hole in the lung (bronchopleural fistula), or uncontrolled pressure inside your head would also mean you couldn't take part. Also, if you have certain injuries to your upper digestive system that would make it difficult to place a special tube (called an esophageal balloon) for measurements, you would not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in intensive care?
Do you have an 'open abdomen' after surgery?
Are you already using the AbClo device?
Are you connected to a breathing machine?
Do you have stable blood pressure and normal blood clotting?

Answer every question to see your result.

What does participation involve?

If you join this study, you will already be using the AbClo device. Researchers will take measurements of how your lungs are working at different times. This will involve checking things like lung pressure, how much air your lungs hold, and how well your blood is getting oxygen. These measurements will be done before and after the AbClo device is adjusted to certain settings recommended by the manufacturer. They will also take measurements after your tummy has been surgically closed. You won't be given any new medication for this study, and the tests will be done while you are still an inpatient. The total time you spend in the study will depend on your hospital stay and recovery.

Potential risks and benefits

This study aims to understand and improve care for patients like you. A potential benefit is helping doctors learn how to better manage breathing support when using the AbClo device, which could improve outcomes for future patients. There are no new procedures or medications involved beyond your standard care; the study mainly involves taking extra measurements. As with any medical procedure or device, there are always potential, though rare, risks associated with treatment, and the study will not introduce any additional risks beyond those of your standard care. You have the right to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is an 'open abdomen'?

After some major tummy operations, the wound might be left open to heal. This is known as an 'open abdomen'.

What does the AbClo device do?

It's like a gentle belt that helps to bring the tummy muscles together, which helps the wound to close and heal.

Will I get new medicines if I join?

No, you won't be given any new medicines as part of this study. It's about taking extra measurements.

How long will I be in the study?

The study will involve measurements taken at different points during your hospital stay, until your tummy wound is closed.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any time, and it won't affect your medical care.

How to find out more

Nattapat Wongtirawit, M.D.

nattapat.wongtirawit@unityhealth.to 416-864-6060 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.