Botulinum toxin in open abdomen closure. A multicentric randomized controlled single-blind clinical trial to evaluate the efficacy of early administration of botulinum toxin for primary midline closure in patients with an open abdomen.
This study is investigating a new way to help people whose tummies have been left open after surgery. Sometimes, after a serious operation, a surgeon needs to leave the abdomen (tummy area) open. This is called an 'open abdomen'. The study is looking at whether giving a medicine called botulinum toxin (Dysport) early on can help the tummy muscles relax and make it easier to close the wound with stitches. Researchers want to find out what percentage of people can have their tummy muscles closed this way without needing a permanent mesh. They will also look at side effects, how long it takes to close the wound, and how people feel afterwards.
At a glance
What is this study about?
Imagine you've had a very serious operation on your tummy, and for a medical reason, the surgeon can't fully close your tummy muscles right away. This is called an 'open abdomen', and it's a temporary but important step to help you heal. Doctors then try to close this opening as safely and quickly as possible.
This study is trying to find a better way to help close these open abdomens. They are looking at a medicine called botulinum toxin, which you might know as 'Botox' or, in this study, 'Dysport'. This medicine temporarily relaxes muscles. The idea is that if the muscles around the open wound are relaxed, it might be easier for doctors to bring the edges of the tummy together and close them with stitches, hopefully avoiding more complex procedures later on.
The main goal of the study is to see how many patients can have their tummy muscles stitched back together after receiving this medicine, without needing a permanent mesh to bridge the gap. They will also be carefully checking for any side effects from the medicine, how long it takes for the wound to close, how well people recover, and their general quality of life. This is a Phase IV study, which means the medicine is already approved for other uses, and doctors are now studying its use for this specific condition.
Key takeaways
- This study investigates if botulinum toxin (Dysport) helps close open abdomens.
- It aims to make it easier to stitch tummy muscles together without permanent mesh.
- Researchers will monitor for side effects and how quickly wounds close.
- Your quality of life will be checked at 1 and 6 months after treatment.
- Participation is for adults with an open abdomen, regardless of sex.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or older. No matter your age beyond 18, or if you are male or female, you might be able to take part.
You would need to be a patient who has an 'open abdomen' after surgery. This means your tummy area has been intentionally left open by surgeons for medical reasons.
There may be other very specific medical reasons why you might not be able to join, which will be discussed by your medical team.
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 currently have an 'open abdomen' after surgery?
- Are you willing to receive an injection of the study medicine?
- Are you able to attend follow-up appointments and complete questionnaires for up to 6 months?
What does participation involve?
If you decide to take part, you would receive the study medicine, Dysport, as an injection. Researchers will then closely monitor your progress. They will check how well your tummy muscles are coming together for closure with stitches.
They will also keep a close eye on any side effects you might experience, especially issues related to the medicine or at the injection site. Your recovery time, how long it takes for your wound to be closed, and your general health will be recorded. You'll be asked to complete questionnaires about your quality of life at 1 month and 6 months after the procedure. Doctors will also check for any further issues like hernias at 6 months. The total duration of active follow-up for some assessments is 6 months, but immediate impact like side effects are checked up to 30 days.
Potential risks and benefits
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Common questions
What is an 'open abdomen'?
An 'open abdomen' is when a surgeon intentionally leaves the tummy muscles and skin open after a serious operation, often to allow for swelling or further treatments.
What is botulinum toxin (Dysport)?
Botulinum toxin (Dysport) is a medicine that temporarily relaxes muscles. It's used in this study to see if it makes closing an open abdomen easier.
Will I get 'Botox' like for wrinkles?
The medicine is similar to what's used for wrinkles, but in this medical study, it's used to help relax specific tummy muscles to aid in wound closure.
How long will I be monitored for?
You will be closely monitored for around 30 days for immediate side effects, and your progress will be checked up to 6 months regarding wound healing and quality of life.
What if the medicine doesn't work?
The study is designed to see if it works. If it doesn't, your medical team will continue with standard care options to close your open abdomen.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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