TympanoplastyNCT07496112
Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration
An observational study of Tympanoplasty, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
Trial summary
Radical cavities resulting from open tympanoplasty performed for chronic cholesteatomatous otitis may lead to postoperative complications and negatively affect patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanoplasty
- What is being tested?
- Mastoid cavity obliteration with S53P4 bioactive glass
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Active cholesteatoma
- Earlier radiation of Head and Neck area
- Pregnancy
- Important systemic comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Quality of Life After Radical Cavity Revision and Obliteration With S53P4 Bioactive Glass Granules
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.
Read more
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
- Being tested
- Mastoid cavity obliteration with S53P4 bioactive glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastoid cavity obliteration with S53P4 bioactive glassProcedure or surgery
Surgical obliteration of symptomatic radical mastoid cavities using S53P4 bioactive glass as obliterative material during revision surgery after previous open tympanoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Radical cavity obliteration with S53P4 bioactive glass | Adult patients with symptomatic radical mastoid cavities after previous open tympanoplasty undergoing obliteration using S53P4 bioactive glass. Receives: Procedure: Mastoid cavity obliteration with S53P4 bioactive glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after surgery
Secondary outcomes (5)
Change in quality of life (GBI score)
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)
Measured: 3 months after surgery
Change in audiometric hearing thresholds
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)
Measured: 3 months after surgery
Resolution of otorrhea
Resolution or improvement of otorrhea assessed clinically and defined as absence of ear discharge at follow-up.
Unit of Measure: Percentage of participants
Measured: 3 months after surgery
External auditory canal condition
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.
Measured: 3 months after surgery
Change in cavity volume
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)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TympanoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Di Bari, MD, Principal investigator, ASST Ovest Milanese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496112
- Sponsor's protocol ID
- 16-2025
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Quality of Life After Radical Cavity Revision and Obliteration With S53P4 Bioactive Glass Granules
- ClinicalTrials.gov ID
- NCT07496112
- Acronym / sponsor ID
- 16-2025
- Conditions
- Tympanoplasty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di LegnanoUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical cavity obliteration with S53P4 bioactive glass | – | Procedure: Mastoid cavity obliteration with S53P4 bioactive glassAdult patients with symptomatic radical mastoid cavities after previous open tympanoplasty undergoing obliteration using S53P4 bioactive glass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Active cholesteatoma
- Earlier radiation of Head and Neck area
- Pregnancy
- Important systemic comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mastoid cavity obliteration with S53P4 bioactive glassSurgical obliteration of symptomatic radical mastoid cavities using S53P4 bioactive glass as obliterative material during revision surgery after previous open tympanoplasty. | Procedure or surgery | Radical cavity obliteration with S53P4 bioactive glass |
Primary outcome
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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matteo Di Bari, MD principal investigator
ASST Ovest Milanese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanoplasty, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4 (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.