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NCT Number: NCT07496112

Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

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.

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Key information

Conditions

Tympanoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trial Office

Legnano, Italy, 20025

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4

    Time frame: 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).

Secondary outcomes

  1. Change in quality of life (GBI score)

    Time frame: 3 months after surgery

    Change in quality of life assessed using the Glasgow Benefit Inventory (GBI), a validated questionnaire with scores ranging from -100 to +100, where higher scores indicate greater benefit. The outcome is defined as the mean postoperative GBI total score.

    Unit of Measure: Points (GBI score)

  2. Change in audiometric hearing thresholds

    Time frame: 3 months after surgery

    Change from baseline in audiometric hearing thresholds measured by pure-tone audiometry. The outcome is defined as the mean change in hearing threshold levels between preoperative and postoperative assessments.

    Unit of Measure: Decibels (dB)

  3. Resolution of otorrhea

    Time frame: 3 months after surgery

    Resolution or improvement of otorrhea assessed clinically and defined as absence of ear discharge at follow-up.

    Unit of Measure: Percentage of participants

  4. External auditory canal condition

    Time frame: 3 months after surgery

    Condition of the external auditory canal assessed by otoscopy and graded using the Merchant scale, with the objective of achieving a dry ear.

    Unit of Measure: Merchant scale score from 0 to 4, where 0 indicates no vertigo and 4 indicates severe vertigo with significant disability.

  5. Change in cavity volume

    Time frame: 3 months after surgery

    Change in cavity volume measured using water filling of the ear canal. The outcome is defined as the difference between preoperative and postoperative cavity volume.

    Unit of Measure: Milliliters (mL)

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Other

Registry information

Official study title

Impact of Quality of Life After Radical Cavity Revision and Obliteration With S53P4 Bioactive Glass Granules

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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