Evaluating the safety of S53P4 bioactive glass for mastoid cavity treatment
The Short- and Long-Term Safety of S53P4 Bioactive Glass for Mastoid Obliteration: a Retrospective Comparative Study
This study is testing if a new type of bioactive glass is safe to use for treating the ear after surgery, specifically for patients who had mastoid surgery between 2010 and 2022.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | All |
| Sponsor | Diakonessenhuis, Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06160388 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the safety of S53P4 bioactive glass used for mastoid obliteration following mastoidectomy procedures. The study focuses on patients who underwent either canal wall up or canal wall down mastoidectomy between 2010 and 2022. By analyzing data collected from these patients, the study aims to provide insights into the safety profile of this synthetic material compared to traditional autologous options. The findings could help inform best practices for mastoid cavity management.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone canal wall up or canal wall down mastoidectomy between 2010 and 2022.
Not a fit: Patients who have undergone other surgical techniques, such as subtotal petrosectomy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of mastoid cavity treatments, potentially improving patient outcomes.
How similar studies have performed: While comparative studies on obliteration materials are rare, the use of bioactive glass in similar contexts has shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Canal wall up or canal wall down mastoidectomy * Operated between 2010 and 2022 * All indications are included Exclusion Criteria: * Other surgical techniques, such as subtotal petrosectomy
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: 0882506172
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.