Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
This study is investigating a new medical device called Fasciotens-Abdomen. It's for patients who need an 'open abdomen' after severe conditions like serious infections, swelling, or injuries inside their tummy. When the tummy is left open, the muscles and skin can pull back, making it very hard to close later. This device works by gently pulling the edges of the tummy muscles together to stop them from retracting. The main goal is to check if the Fasciotens-Abdomen device works as intended and is easy for doctors to use. If successful, it could help improve how these difficult cases are managed, potentially making future tummy closure operations simpler and reducing complications.
At a glance
What is this study about?
Sometimes, after very serious operations or conditions like severe infections or swelling inside the tummy, doctors can't close the wound straight away. They might need to leave the tummy 'open' for a while – this is called an open abdomen. This can happen if there's too much swelling inside, or if more operations are needed soon. When the tummy is left open, the layers of muscle and skin can naturally pull back, making it much harder for doctors to close the wound later on. This can lead to more complications and difficult surgeries down the line.
This study is looking at a new device called Fasciotens-Abdomen. It's designed to gently pull on the edges of the tummy muscles and skin from the moment the tummy is opened. The idea is to keep these layers from pulling back too much. This is a new approach, as older methods often only address the issue after the muscles have already retracted.
The main aim of this study is to see if the Fasciotens-Abdomen device works well to prevent this pulling back of the tummy muscles. Researchers also want to make sure it's practical and safe for doctors to use. If it proves to be effective, this device could make a big difference in how doctors manage patients with open abdomens, potentially leading to better outcomes and fewer problems for patients in the long run.
Key takeaways
- This study evaluates a new device for managing open abdomen.
- The device aims to prevent tummy muscles from retracting.
- It could make future tummy closure operations easier.
- Participation involves using the device as part of standard care.
- The study hopes to improve outcomes for patients with open abdomens.
Who may be eligible?
To be part of this study, you need to be an adult (18 years or older) and have had a specific type of open tummy operation where a special absorbable net has been used, and another operation (a 'second look') is planned or needed.
There are certain reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have a very severe heart or lung condition. Also, if you have open wounds or infections where the device would touch your skin, or if your rib cage or pelvis isn't stable enough for the device to be used, you wouldn't be able to take part.
Finally, if you are extremely unwell with a very short life expectancy, have serious mental health issues requiring hospitalisation by law, or work closely with the main researcher, you wouldn't be able to participate. Your doctor will carefully check all these points to see if this study is right for you.
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?
- Do you have an open abdomen with a special net and further surgery planned?
- Are you NOT pregnant or breastfeeding?
- Do you have stable bones in your chest and pelvis?
- Do you NOT have serious heart or lung failure?
- Are there no open wounds or infections where the device would touch?
What does participation involve?
If you decide to take part, the Fasciotens-Abdomen device will be used during your treatment for an open abdomen. This means the device would be fitted to help keep your tummy muscles from pulling back. You will be monitored closely by your medical team throughout your stay, just as any patient with an open abdomen would be. The study will mainly observe how the device works and whether it helps prevent the retraction of your tummy muscles. There aren't any extra visits or medications specifically for this study beyond your standard medical care; the focus is on seeing how this new device performs during your already planned treatment. The total duration of your participation will depend on how long you need the open abdomen treatment, as the device will be used during that period.
Potential risks and benefits
Locations (1)
- Klinik für Allgemein-, Viszeral- und TransplantationschirurgieVerified postcodeAachen, Germany· Recruiting
Common questions
What is an 'open abdomen'?
It's when your tummy wound is left open after an operation, usually because of severe swelling or infection inside, and it can't be closed immediately.
What does the Fasciotens-Abdomen device do?
It's a device designed to gently pull the edges of your tummy muscles together to stop them from pulling back when your tummy is left open.
Is this device surgery?
No, it's a device used after your initial tummy operation, fitted externally to help manage the open wound.
Will I get different medical care if I join the study?
The study focuses on using this specific device as part of your existing treatment plan. Your overall medical care will remain the same and will be tailored to your needs.
How long will I be in the study?
You'll be part of the study for as long as you need the open abdomen treatment where the device is used.
How to find out more
Roman Marius Eickhoff, Dr. med.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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