Using bioactive glass to improve old mastoid cavity surgeries
Efficacy of Secondary Obliteration of Chronically Discharging Old Radical Cavities Using S53P4 Bioactive Glass
Diakonessenhuis, Utrecht · NCT06116513
This study is testing if a special type of glass can help improve healing and reduce problems after surgery for people who had old mastoid cavity surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Sex | All |
| Sponsor | Diakonessenhuis, Utrecht (other) |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06116513 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of S53P4 bioactive glass for secondary obliteration of old radical mastoid cavities. The procedure aims to reconstruct the posterior wall of the external auditory canal to reduce postoperative complications such as otorrhea, pain, and dizziness. The study will evaluate outcomes based on the Merchant grading scale for postoperative otorrhea, focusing on the material's volume retention and antibacterial properties. Participants will have undergone canal wall down surgeries between 2011 and 2022.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had canal wall down surgeries resulting in old mastoid cavities.
Not a fit: Patients with middle ear cholesteatoma or those who have previously undergone obliteration will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications for patients with old mastoid cavities.
How similar studies have performed: While this approach is innovative, similar studies using bioactive materials for surgical reconstruction have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Old canal wall down cavity * Operated between 2011 and 2022 Exclusion Criteria: * Middle ear cholesteatoma * Previous obliteration
Where this trial is running
Utrecht
- Diakonessenhuis — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: J.J. Quak, MD, PhD — Diakonessenhuis, Utrecht
- Study coordinator: Leij-Halfwerk, Msc, Ir
- Email: Wetenschapsbureau@diakhuis.nl
- Phone: 088-250 6172
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.
Conditions: Mastoid Cavity