Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

NCT07496112 | Enrolling By Invitation

• 1 other identifier: 16-2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4

  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).

  3 months after surgery

Secondary Outcomes (6)

• Change in quality of life (GBI score)

  3 months after surgery

• Change in disease-specific quality of life

  3 months after surgery

• Change in audiometric hearing thresholds

  3 months after surgery

• Resolution of otorrhea

  3 months after surgery

• External auditory canal condition

  3 months after surgery

Study Arms (1)

Radical cavity obliteration with S53P4 bioactive glass

Adult patients with symptomatic radical mastoid cavities after previous open tympanoplasty undergoing obliteration using S53P4 bioactive glass.

Procedure: Mastoid cavity obliteration with S53P4 bioactive glass

Interventions

Mastoid cavity obliteration with S53P4 bioactive glass PROCEDURE

Surgical obliteration of symptomatic radical mastoid cavities using S53P4 bioactive glass as obliterative material during revision surgery after previous open tympanoplasty.

Radical cavity obliteration with S53P4 bioactive glass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients requiring rehabilitation of radical open cavity after a previous canal wall down tympanoplasty. The trial will include at least 50 consecutives patients whom it is planned rehabilitation of radical cavity and mastoid obliteration with S53P4 Bonalive granules. Patients with a history of canal wall down (CWD) tympanoplasty who present with persistent symptoms such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included.

You may qualify if:

• 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

You may not qualify if:

• Active cholesteatoma
• Earlier radiation of Head and Neck area
• Pregnancy
• Important systemic comorbidities

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano: lead

Study Sites (1)

Trial Office

Legnano, Italy, 20025, Italy

Location

MeSH Terms

Interventions

bioactive glass S53P4

Study Officials

• Matteo Di Bari, MD

  ASST Ovest Milanese

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)