RecruitingOBSERVATIONAL

Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"

This study is for adults who need surgery for a condition called cholesteatoma. Cholesteatoma is a non-cancerous growth that can happen behind your eardrum. After removing it, surgeons often fill the space in the ear bone to help prevent the cholesteatoma from returning. This study is testing two different types of special glass, named GlassBONE™ and Bonalive™, to see how well they work for this purpose. The researchers will be checking how patients recover after surgery and how the glass material performs over time. This includes looking at healing, hearing, and how patients feel overall.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrolment target

Start

29 Sep 2023

Estimated completion

01 Apr 2027

Cholesteatoma

What is this study about?

This study is looking into a problem called cholesteatoma. This is a skin growth that can develop in your middle ear, behind the eardrum. If left untreated, it can cause problems like hearing loss or infections. The usual treatment is surgery to remove the growth. After removing the cholesteatoma, surgeons often need to fill in a space in the mastoid bone (a bone in your skull behind your ear) to help stop the cholesteatoma from growing back. This study aims to find out which of two special types of glass material, called bioactive glass (GlassBONE™ or Bonalive™), works best for this filling.

The main goal is to see if these glass materials can help keep the area stable and prevent the cholesteatoma from returning. The researchers will be carefully following patients who have this surgery to see how they heal, how their hearing changes, and how they feel after the operation. By comparing the two different glass materials, doctors hope to learn which one is most effective for patients in the future.

This research is important because it could lead to better surgical outcomes for people with cholesteatoma, potentially reducing the chance of the condition coming back and improving their long-term health and well-being. It’s about finding the best way to help patients recover and live well after this type of ear surgery.

Key takeaways

Tests two types of special glass after cholesteatoma surgery.
Aims to prevent the cholesteatoma from returning.
Involves regular follow-up appointments and scans for 18 months.
Looks at healing, hearing, and quality of life.
For adults with cholesteatoma who need first-time surgery.

Who may be eligible?

This study is specifically looking for adults, aged 18 years and older, who have been diagnosed with cholesteatoma for the first time. You must need surgery for this condition, and this surgery must involve filling the mastoid bone (part of your ear bone) after the cholesteatoma is removed.

There are also some reasons why you might not be able to join. For example, if you've already had surgery for cholesteatoma, or if your cholesteatoma is a type that needs a different surgical approach. You also can't take part if you are pregnant, breastfeeding, or if you have certain other ear problems or conditions that would make using the special glass materials unsafe or inappropriate.

The study also cannot include people who are unable to give their own consent or are already taking part in other specific medical research studies that might interfere with this one.

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 cholesteatoma that needs surgery?
Is this your first surgery for cholesteatoma?
Are you able to attend follow-up appointments for 18 months?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have surgery to remove your cholesteatoma under general anaesthetic, just like usual. During this surgery, one of the two types of special glass will be used to fill the space in your ear bone. After your surgery, you'll get a phone call the next morning to check how you're feeling. You'll also have several follow-up appointments at the hospital. These appointments will be around 8 days, 45 days, 3 months, 6 months, and 18 months after your surgery.

At these appointments, doctors will check your ear, perform hearing tests, and you'll also complete questionnaires about your quality of life. Around 45 days after surgery, and again at 6 and 18 months, you'll have a special type of scan called a CBCT (cone beam CT scan). This helps the doctors see how the glass material is doing inside your ear. The total duration of your participation in the study will be about 18 months.

Potential risks and benefits

Taking part in this study means you'll receive the standard surgical care for your cholesteatoma, with the added benefit of being carefully monitored throughout your recovery. The special glass materials aim to help prevent the cholesteatoma from returning, which could be a significant benefit. As with any surgery, there are always potential risks such as infection, bleeding, or issues with healing, but these are carefully managed by your medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital Lyon Sud
Verified postcode
Lyon, France· Recruiting

Common questions

What is cholesteatoma?

It's a non-cancerous growth of skin cells that develops in the middle ear, behind the eardrum. It can cause problems if not treated.

What is 'bioactive glass'?

It's a special type of glass material designed to be used in the body. In this study, it's used to fill a space in the ear bone after surgery.

Will I know which type of glass I receive?

The study aims to compare two different types of glass. Your doctor will discuss the details of your treatment with you.

How long will I be followed in the study?

You will be followed for about 18 months after your surgery with several check-up appointments and scans.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your medical care.

How to find out more

Maxime fieux

maxime.fieux@chu-lyon.fr 04.72.66.64.15 Official trial record

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