RecruitingNAINTERVENTIONAL

A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive

This study is testing a new dissolvable bone glue, called Tetranite, which is designed to help fix a piece of skull bone (a 'cranial flap') back in place after brain surgery. The main aim is to check if it's safe for patients and effective at holding the bone firmly. Doctors will be looking at how well the glue works both immediately after surgery and six months later. If this initial study shows promising results, it could lead to the glue being tested in more patients in the future, potentially offering a new way to help people recover after certain types of brain surgery.

At a glance

Status

Recruiting

Phase

Sponsor

RevBio

Enrolment target

Start

15 Jan 2025

Estimated completion

15 Jan 2027

Craniotomy

What is this study about?

When someone has brain surgery, doctors often need to temporarily remove a piece of skull bone to access the brain. This piece of bone is called a 'cranial flap'. After the surgery, the flap is put back in place and usually held with small plates or screws. This study is exploring a new approach using a special type of dissolvable bone glue, called Tetranite, to see if it can securely fix the flap.

The main purpose of this initial study is to find out if Tetranite is safe for people to use and if it works well. The doctors will be carefully watching for any problems or side effects after the surgery. They'll also be checking to see how firmly the glue holds the bone flap, both straight after the operation and again a few months later using special scans.

If this small study shows that Tetranite is safe and effective, it means doctors might be able to offer it to more patients in the future. The hope is that this new glue could provide a good way to help patients recover after certain brain surgeries where a piece of the skull needs to be put back.

Key takeaways

This study evaluates a dissolvable bone glue, Tetranite, for skull bone fixation after brain surgery.
The primary focus is on ensuring the glue's safety and how well it holds the bone in place.
Participation involves using the glue during surgery and attending follow-up checks for up to 6 months.
It's an early-stage study to see if the glue can be tested in more patients later.
Your medical care will not be affected if you choose not to participate or withdraw.

Who may be eligible?

To join this study, you would generally need to be an adult between 18 and 75 years old who is scheduled for a specific type of brain surgery where a piece of your skull is temporarily removed. This surgery would need to be in a particular area of the brain, and the wound must be clean and uninfected. You and your family would also need to be able and willing to understand what the study involves and agree to take part, and you must be able to attend all follow-up appointments and scans.

There are also some reasons why you might not be able to join. For example, if your surgery involves certain tricky areas like the ear or nose passages, or if the opening in the skull bone is very wide in some places. You also wouldn't be able to join if you have certain existing brain conditions, have had similar brain surgery in the same spot before, or if you will need radiation treatment to the surgery site afterwards. Specific types of cancer treatment or a very short life expectancy also mean you wouldn't be suitable for this study.

Quick self-check

Are you between 18 and 75 years old?
Are you having brain surgery where a piece of your skull bone is removed and put back?
Is your surgery in a specific, clean area of the brain?
Are you able to attend follow-up appointments and scans for up to 6 months?
Have you *not* had radiation or certain chemotherapy recently to the surgery site?
Do you *not* have certain existing brain conditions or a very short life expectancy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part in this study, the Tetranite glue would be used instead of traditional methods to fix your skull bone flap during your scheduled brain surgery. After your surgery, the study team would monitor you closely for any side effects or problems. You would need to attend follow-up appointments for up to 6 months after your operation, and these would include special scans (like CT scans) to see how the glue is performing and how your bone is healing. You might also be asked to answer some questionnaires about how you are feeling and recovering.

Potential risks and benefits

Potential benefits of taking part could include using a new dissolvable product that may offer a different way to fix the skull bone after surgery. However, as this is a new treatment being tested, there might be unforeseen risks or side effects that we don't know about yet. The main goal of this study is to check for these by monitoring your safety very carefully after the procedure. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Bristol Southmead Hospital
Bristol, United Kingdom· Recruiting

Common questions

What is 'Tetranite'?

Tetranite is a new type of special glue designed to dissolve over time, used here to help fix a piece of skull bone back in place after brain surgery.

Why is this glue being tested?

Doctors want to see if this dissolvable glue is a safe and effective way to hold the skull bone firm after surgery, potentially offering a different option to traditional plates and screws.

What is a 'cranial flap'?

A cranial flap is the piece of skull bone that is temporarily removed during certain brain operations to allow doctors to access the brain.

Will I have extra procedures if I join?

Your main surgery would be the same, but you would have extra follow-up appointments and scans afterwards specifically for the study to check on the glue.

Can I stop being part of the study once I've joined?

Yes, absolutely. You can decide to leave the study at any time, and this will not affect the quality of your medical care.

How to find out more

Brian Hess

bhess@revbio.com 617-460-6675 Official trial record

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