Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mastoid cavity obliteration with S53P4 bioactive glass.
- Who it may be relevant to
- Registry conditions: Tympanoplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Quality of Life After Radical Cavity Revision and Obliteration With S53P4 Bioactive Glass Granules
Overview
Radical cavities resulting from open tympanoplasty performed for chronic cholesteatomatous otitis may lead to postoperative complications and negatively affect patients' quality of life. These cavities can remain unstable and may be associated with persistent otorrhea, limitations in the use of hearing aids, and the need to avoid water exposure, all of which may significantly impact daily activities. Although mastoid and paratympanic cavity obliteration techniques are increasingly used during primary surgery, many patients previously treated with open tympanoplasty continue to present with problematic postoperative cavities. Obliteration procedures have been proposed in revision surgery to improve cavity stability and reduce complications. Bioactive glass S53P4 has recently attracted interest as an obliterative material due to its long-term stability, biocompatibility, antibacterial properties, and ability to integrate with surrounding tissues. However, evidence regarding the medium-term clinical outcomes of this approach remains limited. The aim of this study is to evaluate the clinical effectiveness and safety of mastoid cavity obliteration using bioactive glass S53P4 in patients with radical cavities following open tympanoplasty. The study will assess surgical success, complication rates, and the impact of the procedure on patient quality of life.
Interventions
- Procedure Mastoid cavity obliteration with S53P4 bioactive glass
Surgical obliteration of symptomatic radical mastoid cavities using S53P4 bioactive glass as obliterative material during revision surgery after previous open tympanoplasty.
Primary outcome measures
- Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4 [Time frame: 3 months after surgery]
Secondary outcome measures (5)
- Change in quality of life (GBI score) [Time frame: 3 months after surgery]
- Change in audiometric hearing thresholds [Time frame: 3 months after surgery]
- Resolution of otorrhea [Time frame: 3 months after surgery]
- External auditory canal condition [Time frame: 3 months after surgery]
- Change in cavity volume [Time frame: 3 months after surgery]
Eligibility criteria
Inclusion criteria
- underwent a canal wall down tympanoplasty or a previous obliteration attempt more than a year ago
- present with symptoms related to unstable cavity such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included
- patients Over 18 years who signed informed consent
Exclusion criteria
- Active cholesteatoma
- Earlier radiation of Head and Neck area
- Pregnancy
- Important systemic comorbidities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Trial Office — Legnano
Identifiers
NCT: NCT07496112 · 16-2025