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Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

NCT07496112 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-03

No results posted yet for this 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.

Conditions

  • Tympanoplasty

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.

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

    lead OTHER

Principal Investigators

  • Matteo Di Bari, MD · ASST Ovest Milanese

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-05-01
Completion
2027-05-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496112 on ClinicalTrials.gov