Tympanic Membrane PerforationNCT07834892
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
A study testing Conchal Cartilage and Perichondrium Tympanoplasty and Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty in people with Tympanic Membrane Perforation and Otitis Media, run by Assiut University.
Trial summary
Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanic Membrane Perforation, Otitis Media, Suppurative Otitis Media
- What is being tested?
- Conchal Cartilage and Perichondrium Tympanoplasty and Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years and older
- Presence of a large or subtotal tympanic membrane perforation
- Safe chronic suppurative otitis media (CSOM)
- Undergoing primary or revision tympanoplasty
Who cannot join
- Unsafe ear (e.g., presence of cholesteatoma, marginal perforation, or attic pathology)
- Small or medium-sized tympanic membrane perforations
- Age younger than 18 years
- Patients unwilling or unable to attend scheduled postoperative follow-up visits through 6 months
About this study
Official title: Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)
Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer of temporalis fascia over the cartilage graft improves anatomical closure and functional hearing.
The primary purpose of this study is to determine whether adding a temporalis fascia layer to a conchal cartilage and perichondrium graft improves graft healing rates and audiological outcomes in patients undergoing tympanoplasty for large or subtotal perforations.
Read more
Adult participants with safe chronic suppurative otitis media and large or subtotal tympanic membrane perforations are randomly assigned in a 1:1 ratio to one of two surgical arms:
- Group A:Tympanoplasty using an autologous conchal cartilage graft with attached perichondrium alone.
- Group B: Tympanoplasty using an autologous conchal cartilage and perichondrium graft reinforced with an additional outer layer of temporalis fascia placed between the cartilage and the tympanic membrane remnant.
All participants undergo clinical otomicroscopy/otoendoscopy to assess graft take, healing, and complications, alongside pure-tone audiometry (evaluating air-bone gap and hearing thresholds) preoperatively and at 6 months postoperatively.
- Conditions
- Tympanic Membrane Perforation, Otitis Media, Suppurative Otitis Media, Chronic Suppurative Otitis Media
- Being tested
- Conchal Cartilage and Perichondrium Tympanoplasty, Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty
- Keywords
- Tympanoplasty, Cartilage Tympanoplasty, Temporalis Fascia, Conchal Cartilage, Myringoplasty, Air-Bone Gap, Graft Take
- Medical subject headings
- Tympanic Membrane Perforation, Otitis Media, Otitis Media, Suppurative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conchal Cartilage and Perichondrium TympanoplastyProcedure or surgery
Surgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage graft with attached perichondrium alone.
Conchal Cartilage, Perichondrium, and Temporalis Fascia TympanoplastyProcedure or surgery
Surgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage and perichondrium graft combined with an additional layer of temporalis fascia positioned outside the cartilage graft between the cartilage and the tympanic membrane remnant.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cartilage and Perichondrium | Active comparator | Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone. Receives: Procedure: Conchal Cartilage and Perichondrium Tympanoplasty |
| Group B: Cartilage, Perichondrium, and Temporalis Fascia | Experimental | Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium combined with an additional temporalis fascia layer placed outside the cartilage graft between the cartilage and the tympanic membrane remnant. Receives: Procedure: Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Tympanic Membrane Closure
Evaluated by otomicroscopic or otoendoscopic examination. Complete closure is defined as an intact graft with total epithelialization and closure of the tympanic membrane perforation, with no residual or recurrent perforation.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Saad Khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834892
- Sponsor's protocol ID
- Cartilage-Fascia Tympanoplasty
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)
- ClinicalTrials.gov ID
- NCT07834892
- Acronym / sponsor ID
- Cartilage-Fascia Tympanoplasty
- Conditions
- Tympanic Membrane Perforation, Otitis Media, Suppurative Otitis Media, Chronic Suppurative Otitis Media
- Keywords
- Tympanoplasty, Cartilage Tympanoplasty, Temporalis Fascia, Conchal Cartilage, Myringoplasty, Air-Bone Gap, Graft Take
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Sep 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.
Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer of temporalis fascia over the cartilage graft improves anatomical closure and functional hearing.
The primary purpose of this study is to determine whether adding a temporalis fascia layer to a conchal cartilage and perichondrium graft improves graft healing rates and audiological outcomes in patients undergoing tympanoplasty for large or subtotal perforations.
Adult participants with safe chronic suppurative otitis media and large or subtotal tympanic membrane perforations are randomly assigned in a 1:1 ratio to one of two surgical arms:
- Group A:Tympanoplasty using an autologous conchal cartilage graft with attached perichondrium alone.
- Group B: Tympanoplasty using an autologous conchal cartilage and perichondrium graft reinforced with an additional outer layer of temporalis fascia placed between the cartilage and the tympanic membrane remnant.
All participants undergo clinical otomicroscopy/otoendoscopy to assess graft take, healing, and complications, alongside pure-tone audiometry (evaluating air-bone gap and hearing thresholds) preoperatively and at 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cartilage and Perichondrium | Active comparator | Procedure: Conchal Cartilage and Perichondrium TympanoplastyParticipants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone. |
| Group B: Cartilage, Perichondrium, and Temporalis Fascia | Experimental | Procedure: Conchal Cartilage, Perichondrium, and Temporalis Fascia TympanoplastyParticipants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium combined with an additional temporalis fascia layer placed outside the cartilage graft between the cartilage and the tympanic membrane remnant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older
- Presence of a large or subtotal tympanic membrane perforation
- Safe chronic suppurative otitis media (CSOM)
- Undergoing primary or revision tympanoplasty
Key exclusion criteria (4 listed)
- Unsafe ear (e.g., presence of cholesteatoma, marginal perforation, or attic pathology)
- Small or medium-sized tympanic membrane perforations
- Age younger than 18 years
- Patients unwilling or unable to attend scheduled postoperative follow-up visits through 6 months
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 |
|---|---|---|
| Conchal Cartilage and Perichondrium TympanoplastySurgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage graft with attached perichondrium alone. | Procedure or surgery | Group A: Cartilage and Perichondrium |
| Conchal Cartilage, Perichondrium, and Temporalis Fascia TympanoplastySurgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage and perichondrium graft combined with an additional layer of temporalis fascia positioned outside the cartilage graft between the cartilage and the tympanic membrane remnant. | Procedure or surgery | Group B: Cartilage, Perichondrium, and Temporalis Fascia |
Primary outcome
Rate of Complete Tympanic Membrane Closure
Time frame: 6 months postoperatively
Evaluated by otomicroscopic or otoendoscopic examination. Complete closure is defined as an intact graft with total epithelialization and closure of the tympanic membrane perforation, with no residual or recurrent perforation.
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 22 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conchal Cartilage and Perichondrium Tympanoplasty and Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty in people with Tympanic Membrane Perforation and Otitis Media, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of Complete Tympanic Membrane Closure (time frame: 6 months postoperatively). 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 22 Sep 2026.