Tympanic Membrane PerforationNCT07866222
Outcomes of Cartilage Tympanoplasty in Children
A study testing Cartilage Tympanoplasty in people with Tympanic Membrane Perforation and Conductive Hearing Loss, run by Assiut University.
Trial summary
This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations. A perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Tympanic Membrane Perforation, Conductive Hearing Loss, Chronic Otitis Media
- What is being tested?
- Cartilage Tympanoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 8-18 years
- Large, subtotal central tympanic membrane perforation or persistent same-size central perforation for 6 months before surgery
- Dry perforation for 6 months duration
- Conductive hearing loss attributable to tympanic membrane perforation
- Patients able to undergo preoperative and postoperative audiological assessment
- Written informed consent obtained from the parent/legal guardian and assent from the child when appropriate
Who cannot join
- Cholesteatoma
- Active ear infection at the time of surgery
- Sensorineural hearing loss unrelated to the tympanic membrane perforation
- Conductive gap > 40 dB (suggestive of ossicular chain pathology)
- Congenital middle-ear abnormalities affecting the surgical outcome
About this study
This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations.
A perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Cartilage tympanoplasty is a surgical technique that uses autologous cartilage (the patient's own cartilage tissue) to reconstruct and seal the eardrum. Cartilage is known for its rigidity and resistance to retraction, which may offer advantages in children who frequently experience middle-ear pressure and ventilation issues.
Read more
Children aged 8 to 18 years presenting with large, subtotal, or persistent dry central perforations will undergo cartilage tympanoplasty at Assiut University Hospitals. All participants will undergo standardized pre-surgical and post-surgical evaluations, including otological microscopic examinations and pure-tone audiometry tests.
The main objectives are to evaluate the graft success rate (complete anatomical closure and stability of the eardrum) and to measure functional hearing restoration, specifically changes in air-conduction thresholds and the air-bone gap (ABG).
- Being tested
- Cartilage Tympanoplasty
- Keywords
- Cartilage tympanoplasty, Pediatric tympanoplasty, Myringoplasty, Tympanic membrane repair, Air-bone gap, Graft take rate
- Medical subject headings
- Tympanic Membrane Perforation, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartilage TympanoplastyProcedure or surgery
Surgical reconstruction of the tympanic membrane using an autologous cartilage graft in pediatric patients presenting with large, subtotal, or persistent central perforations. The procedure is performed under general anesthesia to achieve complete anatomical closure of the perforation and restore middle-ear sound conduction.
| Study group | Role | What they receive |
|---|---|---|
| Cartilage Tympanoplasty | Experimental | Pediatric patients aged 8 to 18 years undergoing surgical repair of large, subtotal, or persistent central tympanic membrane perforations using autologous cartilage tympanoplasty to assess anatomical graft uptake and hearing restoration. Receives: Procedure: Cartilage Tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Tympanic Membrane Closure
Assessed by otoscopic and microscopic examination. Complete closure is defined as an intact, fully epithelialized, and stable graft without residual perforation, graft retraction, or lateralization.
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 posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Hussein Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866222
- Sponsor's protocol ID
- Child Cartilage Tympanoplasty
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Cartilage Tympanoplasty in Children
- ClinicalTrials.gov ID
- NCT07866222
- Acronym / sponsor ID
- Child Cartilage Tympanoplasty
- Keywords
- Cartilage tympanoplasty, Pediatric tympanoplasty, Myringoplasty, Tympanic membrane repair, Air-bone gap, Graft take rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 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.
This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations.
A perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Cartilage tympanoplasty is a surgical technique that uses autologous cartilage (the patient's own cartilage tissue) to reconstruct and seal the eardrum. Cartilage is known for its rigidity and resistance to retraction, which may offer advantages in children who frequently experience middle-ear pressure and ventilation issues.
Children aged 8 to 18 years presenting with large, subtotal, or persistent dry central perforations will undergo cartilage tympanoplasty at Assiut University Hospitals. All participants will undergo standardized pre-surgical and post-surgical evaluations, including otological microscopic examinations and pure-tone audiometry tests.
The main objectives are to evaluate the graft success rate (complete anatomical closure and stability of the eardrum) and to measure functional hearing restoration, specifically changes in air-conduction thresholds and the air-bone gap (ABG).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cartilage Tympanoplasty | Experimental | Procedure: Cartilage TympanoplastyPediatric patients aged 8 to 18 years undergoing surgical repair of large, subtotal, or persistent central tympanic membrane perforations using autologous cartilage tympanoplasty to assess anatomical graft uptake and hearing restoration. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children aged 8-18 years
- Large, subtotal central tympanic membrane perforation or persistent same-size central perforation for 6 months before surgery
- Dry perforation for 6 months duration
- Conductive hearing loss attributable to tympanic membrane perforation
- Patients able to undergo preoperative and postoperative audiological assessment
Key exclusion criteria (5 listed)
- Cholesteatoma
- Active ear infection at the time of surgery
- Sensorineural hearing loss unrelated to the tympanic membrane perforation
- Conductive gap > 40 dB (suggestive of ossicular chain pathology)
- Congenital middle-ear abnormalities affecting the surgical outcome
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 |
|---|---|---|
| Cartilage TympanoplastySurgical reconstruction of the tympanic membrane using an autologous cartilage graft in pediatric patients presenting with large, subtotal, or persistent central perforations. The procedure is performed under general anesthesia to achieve complete anatomical closure of the perforation and restore middle-ear sound conduction. | Procedure or surgery | Cartilage Tympanoplasty |
Primary outcome
Percentage of Participants With Complete Tympanic Membrane Closure
Time frame: 6 months postoperatively
Assessed by otoscopic and microscopic examination. Complete closure is defined as an intact, fully epithelialized, and stable graft without residual perforation, graft retraction, or lateralization.
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 8 Oct 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 Cartilage Tympanoplasty in people with Tympanic Membrane Perforation and Conductive Hearing Loss, 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 6 inclusion and 5 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 8 Oct 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?
Percentage of Participants With 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 8 Oct 2026.