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Eardrum repair showdown: which surgical technique wins for better hearing?

NCT ID NCT07149480

Disease control Sponsor: Shaikh Zayed Hospital, Lahore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two surgical techniques for repairing large eardrum holes caused by chronic ear infections. The interlay method places the graft between eardrum layers, while the underlay method places it beneath. Researchers measured hearing improvement in 60 adults to see which technique works better. The goal is to help surgeons choose the best approach for restoring hearing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical procedure (interlay or underlay tympanoplasty)
What this could lead to
If one technique proves better, it could guide surgeons to choose the method that offers better hearing recovery for patients with chronic ear infections.
What could go wrong
This is a small, single-center study with only 60 participants, so results may not apply to all patients. The techniques are already established, so no major breakthrough is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jan 2025

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged l6-60 years, of any gender. * individuals with chronic otitis media characterized by inactive mucosal disease (absence of discharge) accompanied by a large central perforation persisting for at least 6 weeks and exhibiting pure conductive hearing loss as established through pure-tone audiometry. Exclusion Criteria: * Presence of active otitis media manifesting acute infection or discharge. * Patients diagnosed with tympanosclerosis or ossicular necrosis, adversely affecting ossicular chain mobility, as identified in preoperative assessments. * History of ear surgeries, excluding myringotomy, that could potentially impact tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy. * Individuals with sensorineural or mixed hearing loss, as determined by pure-tone audiometry, indicating a possible alternate or additional source of hearing impairment. * Conditions potentially hindering wound healing or compliance with postoperative care, including but not limited to uncontrolled diabetes mellitus or immunodeficiency disorders. * Patients exhibiting eustachian tube dysfunction, as confirmed through clinical evaluation or medical records. * Patients with an active focus of infection in the throat, nose, paranasal sinuses, or oral cavity, as determined by medical records.

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Conditions

The condition(s) this trial relates to.

chronic otitis media conductive hearing loss disorder Hearing Loss, Conductive Tympanic Membrane Perforation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic otitis media Conductive hearing loss Tympanic membrane perforation

Contacts and locations

Locations

  • Shaikh Zayed Medical college/hospital, Lahore

    Lahore, Punjab Province, 54000, Pakistan

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