Chronic Otitis MediaNCT07149480
Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
A study testing Underlay Tympanoplasty and Interlay Tympanoplasty in people with Chronic Otitis Media and Tympanic Membrane Perforation, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
Trial summary
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss. When such perforations do not heal on their own, surgery called tympanoplasty is performed to repair the eardrum and improve hearing. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Chronic Otitis Media, Tympanic Membrane Perforation, Conductive Hearing Loss
- What is being tested?
- Underlay Tympanoplasty and Interlay Tympanoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jan 2025to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaikh Zayed Medical college/hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss. When such perforations do not heal on their own, surgery called tympanoplasty is performed to repair the eardrum and improve hearing.
There are different surgical techniques for tympanoplasty. In the underlay technique, the graft (a small piece of tissue used to repair the hole) is placed beneath the layers of the eardrum. This approach is simpler and commonly used, but it carries risks such as displacement of the graft. In the interlay technique, the graft is positioned between specific layers of the eardrum, which may allow more natural healing and better hearing results, but it is technically more demanding.
Read more
This clinical study will compare the postoperative outcomes of these two techniques-interlay and underlay-among adults with large central perforations of the eardrum caused by chronic otitis media. The main outcomes assessed will include hearing improvement (measured by closure of the air-bone gap on hearing tests).
We hypothesize that the placement of the graft significantly influences surgical success and hearing recovery. By comparing interlay versus underlay techniques, the study aims to identify which method provides better results for patients. The findings may help refine surgical approaches and improve the overall quality of life for individuals undergoing tympanoplasty.
- Being tested
- Underlay Tympanoplasty, Interlay Tympanoplasty
- Keywords
- Tympanoplasty, Interlay Technique, Underlay Technique, Air-Bone Gap (ABG) Closure, Middle Ear Surgery
- 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.
Underlay TympanoplastyProcedure or surgery
Also called Underlay Graft Placement
Tympanoplasty performed using the underlay graft technique, where the graft is positioned beneath all three layers of the tympanic membrane remnant.
Interlay TympanoplastyProcedure or surgery
Also called Interlay Graft Placement
Tympanoplasty performed using the interlay graft technique, where the graft is positioned between the mucosal and fibrous layers of the tympanic membrane.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Underlay Technique) | Experimental | Patients will undergo tympanoplasty using the underlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated, and the temporalis fascia graft will be placed beneath the remaining tympanic membrane layers along the annulus. The flap will then be repositioned, and the external auditory canal will be packed. Receives: Procedure: Underlay Tympanoplasty |
| Group B (Interlay Technique) | Experimental | Patients will undergo tympanoplasty using the interlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated circumferentially. The temporalis fascia graft will be inserted between the fibrous and mucosal layers of the tympanic membrane, particularly beneath the handle of the malleus, before repositioning the flap. Receives: Procedure: Interlay Tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hearing Gain (Closure in Air-Bone Gap)
The average improvement in hearing thresholds, measured by pure-tone audiometry at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. The outcome will be assessed by calculating the difference between the preoperative and postoperative air-bone gap (ABG) values in decibels (dB). This measure evaluates the effectiveness of tympanoplasty in restoring conductive hearing loss.
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 posted2 Sep 2025
- Study start9 Jan 2025
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaikh Zayed Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Israr, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149480
- Sponsor's protocol ID
- ShaikhZayedH1
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
- ClinicalTrials.gov ID
- NCT07149480
- Acronym / sponsor ID
- ShaikhZayedH1
- Keywords
- Tympanoplasty, Interlay Technique, Underlay Technique, Air-Bone Gap (ABG) Closure, Middle Ear Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shaikh Zayed Hospital, LahoreUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 2 Sep 2025 (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.
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss. When such perforations do not heal on their own, surgery called tympanoplasty is performed to repair the eardrum and improve hearing.
There are different surgical techniques for tympanoplasty. In the underlay technique, the graft (a small piece of tissue used to repair the hole) is placed beneath the layers of the eardrum. This approach is simpler and commonly used, but it carries risks such as displacement of the graft. In the interlay technique, the graft is positioned between specific layers of the eardrum, which may allow more natural healing and better hearing results, but it is technically more demanding.
This clinical study will compare the postoperative outcomes of these two techniques-interlay and underlay-among adults with large central perforations of the eardrum caused by chronic otitis media. The main outcomes assessed will include hearing improvement (measured by closure of the air-bone gap on hearing tests).
We hypothesize that the placement of the graft significantly influences surgical success and hearing recovery. By comparing interlay versus underlay techniques, the study aims to identify which method provides better results for patients. The findings may help refine surgical approaches and improve the overall quality of life for individuals undergoing tympanoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Underlay Technique) | Experimental | Procedure: Underlay TympanoplastyPatients will undergo tympanoplasty using the underlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated, and the temporalis fascia graft will be placed beneath the remaining tympanic membrane layers along the annulus. The flap will then be repositioned, and the external auditory canal will be packed. |
| Group B (Interlay Technique) | Experimental | Procedure: Interlay TympanoplastyPatients will undergo tympanoplasty using the interlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated circumferentially. The temporalis fascia graft will be inserted between the fibrous and mucosal layers of the tympanic membrane, particularly beneath the handle of the malleus, before repositioning the flap. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Underlay TympanoplastyAlso: Underlay Graft PlacementTympanoplasty performed using the underlay graft technique, where the graft is positioned beneath all three layers of the tympanic membrane remnant. | Procedure or surgery | Group A (Underlay Technique) |
| Interlay TympanoplastyAlso: Interlay Graft PlacementTympanoplasty performed using the interlay graft technique, where the graft is positioned between the mucosal and fibrous layers of the tympanic membrane. | Procedure or surgery | Group B (Interlay Technique) |
Primary outcome
Mean Hearing Gain (Closure in Air-Bone Gap)
Time frame: 3 months after surgery
The average improvement in hearing thresholds, measured by pure-tone audiometry at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. The outcome will be assessed by calculating the difference between the preoperative and postoperative air-bone gap (ABG) values in decibels (dB). This measure evaluates the effectiveness of tympanoplasty in restoring conductive hearing loss.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underlay Tympanoplasty and Interlay Tympanoplasty in people with Chronic Otitis Media and Tympanic Membrane Perforation, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Hearing Gain (Closure in Air-Bone Gap) (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 2 Sep 2025.