PMCF Study of LiquiBand FIX8® OHMF Device
This study is investigating a new device called LiquiBand FIX8® OHMF, which is designed to help fix medical mesh in place during surgery for a common type of hernia called an inguinal hernia. An inguinal hernia happens when a soft part of your body, usually fat or a piece of intestine, pushes through a weak spot in your tummy muscles, often causing a bulge in your groin. This study aims to check how safe and effective the LiquiBand FIX8® device is when used to repair these hernias. The researchers will be looking at how well patients recover and if there are any problems after the surgery. They want to make sure this new method is beneficial for patients undergoing this common operation.
At a glance
What is this study about?
This study is all about a new tool called LiquiBand FIX8® OHMF. When you have an inguinal hernia, it means there's a weak spot in your lower tummy muscles, near your groin, and something like part of your bowel can push through. To fix this, surgeons often use a mesh to strengthen the area. The new tool, LiquiBand FIX8®, is a special kind of glue designed to hold this mesh in place during an open hernia operation.
The main goal of this study is to see how well this special glue works and if it's safe for people having their first-ever open surgery for an inguinal hernia. They want to make sure it helps patients recover well and doesn't cause any unexpected problems. By carefully watching patients who have surgery using this glue, the research team can gather important information to understand its benefits and any possible downsides.
This research is important because it helps doctors develop better ways to treat common conditions like hernias. If the LiquiBand FIX8® device proves to be safe and effective, it could help improve how these operations are done in the future, potentially leading to better outcomes for many patients in the UK.
Key takeaways
- This study is testing a new glue for fixing hernia mesh during open surgery.
- It's for people having their first inguinal hernia repair.
- The main aim is to check the safety and how well the glue works.
- You'll have follow-up appointments to track your recovery.
- You can stop being part of the study at any time.
Who may be eligible?
To join this study, you need to be an adult (18 or older) and have an inguinal hernia that hasn't been operated on before, meaning it's your first time having surgery for this hernia. You must be planned to have open surgery for this hernia using the LiquiBand FIX8® device and be happy to come for all your follow-up appointments.
There are some reasons why you wouldn't be able to join. For example, if you're having surgery because your hernia has come back after a previous open surgery, or if the doctor thinks your body won't suit this type of repair. You also can't join if you're pregnant or breastfeeding, if you have certain serious health problems, or if you're allergic to any of the ingredients in the LiquiBand FIX8® glue.
Also, if the mesh your surgeon plans to use is made of certain materials (like PTFE or absorbable materials), or if it's a self-gripping mesh, you wouldn't be able to take part. This applies if you have an infection near where the surgery will be, a history of thick scars (keloids), or certain connective tissue disorders.
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 inguinal hernia that needs open surgery for the first time?
- Will your surgeon use the LiquiBand FIX8® glue to fix the mesh?
- Are you able and willing to attend all follow-up appointments?
- Are you NOT pregnant or breastfeeding?
- Do you NOT have a known allergy to cyanoacrylate (a common medical glue ingredient)?
What does participation involve?
If you decide to take part, you'll first have a discussion with the study team and sign a consent form, making sure you understand everything. You will then have your hernia operation as planned, where the LiquiBand FIX8® device will be used to help fix the mesh. The study team will check in with you during your surgery and afterwards. You'll have follow-up appointments after your surgery so the doctors can see how you're recovering and if the device is working well. The whole process, including your surgery and follow-up checks, will last for a certain period, which the doctors will explain to you.
Potential risks and benefits
Locations (3)
- Tameside General HospitalVerified postcodeAshton-under-Lyne, United Kingdom
- James Paget University Hospitals NHS Foundation TrustVerified postcodeGreat Yarmouth, United Kingdom
- Wirral University Teaching Hospital NHS Foundation TrustVerified postcodeMetropolitan Borough of Wirral, United Kingdom
Common questions
What is an inguinal hernia?
An inguinal hernia is when part of your bowel or fatty tissue pushes through a weak spot in your lower tummy muscles, often causing a bulge in your groin area.
What is the LiquiBand FIX8® device?
It's a special type of medical glue designed to securely hold a mesh in place during an open hernia repair surgery, helping to strengthen the weak area.
Will my regular medical care be affected if I join?
No, your decision to join or not join will not affect the quality of your usual medical care.
Who is paying for this study?
This study is a Post-Market Clinical Follow-up (PMCF) study, which means it's usually sponsored by the company that makes the device to gather more information after it's already on the market.
How long will I be involved in the study?
The study involves your surgery and follow-up appointments afterwards. The study team will tell you the exact length of time you'll need to be available for these checks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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