Evaluating the use of bioactive glass for filling the mastoid in cholesteatoma surgery
Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
This study is testing if using a special type of glass to fill in the ear during cholesteatoma surgery helps patients heal better and prevents the problem from coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 1 site (Lyon, Pierre-Bénite) |
| Trial ID | NCT05921643 on ClinicalTrials.gov |
What this trial studies
This observational study involves adult patients with cholesteatoma who are undergoing surgery at the ENT department of Hospices Civils de Lyon. The closed surgical technique will be employed, where a filling material (GlassBONE™ or Bonalive™) is used to stabilize the cartilaginous fragment and prevent recurrence. Patients will be monitored post-operatively through a series of consultations at specified intervals to assess complications, healing, and quality of life. Imaging studies will also be conducted to evaluate the effectiveness of the filling material over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with proven cholesteatoma requiring surgical intervention.
Not a fit: Patients with congenital cholesteatoma, previous surgeries for cholesteatoma, or those requiring an open surgical technique may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce recurrence rates in cholesteatoma patients.
How similar studies have performed: While the use of bioactive glass in mastoid filling is a relatively novel approach, similar studies have shown promising results in other surgical applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients at least 18 years old * Patients with proven cholesteatoma * Patient requiring and agreeing to surgery with filling of the mastoid or tympanic epi (closed technique with filling) * Patient having a surgery with filling in first intention Exclusion Criteria: * Background: * Known outer, middle or inner ear malformation * Congenital cholesteatoma * Previously operated cholesteatoma * Cholesteatoma requiring an open technique or presenting with chronic non-cholesteatomatous otitis * Contraindications to the use of GlassBONE™ or Bonalive™ * Pregnant, parturient or nursing mothers * Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, adults subject to a measure of legal protection or unable to express themselves * Patient participating in interventional research excluding routine care research (old regulations) and category 2 research that does not interfere with the analysis of the primary endpoint * Patient objecting to the use of their data
Where this trial is running
Lyon, Pierre-Bénite
- Hôpital Lyon Sud — Lyon, Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Maxime fieux
- Email: maxime.fieux@chu-lyon.fr
- Phone: 04.72.66.64.15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.