Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4 — 3 months after surgery
  Change in quality of life assessed using the Chronic Otitis Media Questionnaire-12 (COMQ-12). The COMQ-12 is a validated questionnaire with total scores ranging from 0 to 60, where higher scores indicate worse quality of life and greater disease severity. The outcome is defined as the mean change in total COMQ-12 score from preoperative assessment to postoperative follow-up. Unit of measure: Points (COMQ-12 score).

Trial sites (1)

More Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano trials in Italy