Chronic Otitis MediaNCT07595484
A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty
A study testing Wet Temporalis Fascia Graft Tympanoplasty and Dry Temporalis Fascia Graft Tympanoplasty in people with Chronic Otitis Media and Tympanic Membrane Perforation, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
Trial summary
This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Otitis Media, Tympanic Membrane Perforation
- What is being tested?
- Wet Temporalis Fascia Graft Tympanoplasty and Dry Temporalis Fascia Graft Tympanoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2025to 10 Mar 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 60 years.
- Patients of either gender.
- Patients diagnosed with chronic otitis media.
- Patients with inactive mucosal disease, with no active ear discharge.
- Patients with a large central perforation of the tympanic membrane.
- Tympanic membrane perforation persisting for at least 6 weeks.
- Patients with pure conductive hearing loss confirmed on pure-tone audiometry.
Who cannot join
- Patients with active otitis media, acute infection, or active ear discharge.
- Patients with tympanosclerosis or ossicular necrosis affecting ossicular chain mobility.
- Patients with a history of previous ear surgery that could affect tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy, except prior myringotomy.
- Patients with sensorineural hearing loss or mixed hearing loss.
- Patients with conditions impairing wound healing or postoperative care compliance, including uncontrolled diabetes mellitus or immunodeficiency disorders.
- Patients with confirmed Eustachian tube dysfunction.
- Patients with active infection in the throat, nose, paranasal sinuses, or oral cavity.
- Patients with bleeding disorders.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaikh Zayed Medical college/hospital, Lahore
Lahore, Punjab Province, 54000
About this study
This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum.
The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft.
The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.
- Being tested
- Wet Temporalis Fascia Graft Tympanoplasty, Dry Temporalis Fascia Graft Tympanoplasty
- Keywords
- Tympanoplasty, Temporalis fascia graft, Wet temporalis fascia graft, Dry temporalis fascia graft, Tympanic membrane perforation, Large central perforation
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet Temporalis Fascia Graft TympanoplastyProcedure or surgery
Tympanoplasty was performed using a wet temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry
Dry Temporalis Fascia Graft TympanoplastyProcedure or surgery
Tympanoplasty was performed using a dry temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry.
| Study group | Role | What they receive |
|---|---|---|
| Group Wet Temporalis Fascia Graft | Experimental | Participants in this group underwent tympanoplasty using the wet temporalis fascia graft technique for repair of tympanic membrane perforation. Receives: Procedure: Wet Temporalis Fascia Graft Tympanoplasty |
| Group Dry Temporalis Fascia Graft | Active comparator | Participants in this group underwent tympanoplasty using the dry temporalis fascia graft technique for repair of tympanic membrane perforation. Receives: Procedure: Dry Temporalis Fascia Graft Tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean hearing gain after tympanoplasty
Mean hearing gain was measured by comparing the preoperative and postoperative air-bone gap on pure-tone audiometry. The air-bone gap was assessed at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Mean hearing gain was calculated by subtracting the postoperative air-bone gap from the preoperative air-bone gap. A greater reduction in air-bone gap indicated better hearing improvement after tympanoplasty.
Measured: 3 months after surgery
Graft uptake rate after tympanoplasty
Graft uptake rate was assessed by otoscopic examination. A successful graft uptake was defined as an intact and correctly positioned graft with closure of the tympanic membrane perforation, without evidence of graft rejection or active infection.
Measured: 3 months after surgery
Secondary outcomes (1)
Complete Air-Bone Gap Closure
Complete air-bone gap closure was defined as a postoperative air-bone gap of 10 dB or less on pure-tone audiometry. This outcome was used to assess clinically meaningful improvement in conductive hearing loss after tympanoplasty.
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 posted19 May 2026
- Study start10 Sep 2025
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 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
- Investigators
- Hafiz Adil Ikram, Principal investigator, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595484
- Sponsor's protocol ID
- ShaikhZayedH2
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty
- ClinicalTrials.gov ID
- NCT07595484
- Acronym / sponsor ID
- ShaikhZayedH2
- Keywords
- Tympanoplasty, Temporalis fascia graft, Wet temporalis fascia graft, Dry temporalis fascia graft, Tympanic membrane perforation, Large central perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Shaikh Zayed Hospital, LahoreUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 19 May 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 was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum.
The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft.
The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Wet Temporalis Fascia Graft | Experimental | Procedure: Wet Temporalis Fascia Graft TympanoplastyParticipants in this group underwent tympanoplasty using the wet temporalis fascia graft technique for repair of tympanic membrane perforation. |
| Group Dry Temporalis Fascia Graft | Active comparator | Procedure: Dry Temporalis Fascia Graft TympanoplastyParticipants in this group underwent tympanoplasty using the dry temporalis fascia graft technique for repair of tympanic membrane perforation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 60 years.
- Patients of either gender.
- Patients diagnosed with chronic otitis media.
- Patients with inactive mucosal disease, with no active ear discharge.
- Patients with a large central perforation of the tympanic membrane.
Key exclusion criteria (8 listed)
- Patients with active otitis media, acute infection, or active ear discharge.
- Patients with tympanosclerosis or ossicular necrosis affecting ossicular chain mobility.
- Patients with a history of previous ear surgery that could affect tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy, except prior myringotomy.
- Patients with sensorineural hearing loss or mixed hearing loss.
- Patients with conditions impairing wound healing or postoperative care compliance, including 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 |
|---|---|---|
| Wet Temporalis Fascia Graft TympanoplastyTympanoplasty was performed using a wet temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry | Procedure or surgery | Group Wet Temporalis Fascia Graft |
| Dry Temporalis Fascia Graft TympanoplastyTympanoplasty was performed using a dry temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry. | Procedure or surgery | Group Dry Temporalis Fascia Graft |
Primary outcome
Mean hearing gain after tympanoplasty
Time frame: 3 months after surgery
Mean hearing gain was measured by comparing the preoperative and postoperative air-bone gap on pure-tone audiometry. The air-bone gap was assessed at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Mean hearing gain was calculated by subtracting the postoperative air-bone gap from the preoperative air-bone gap. A greater reduction in air-bone gap indicated better hearing improvement after tympanoplasty.
Graft uptake rate after tympanoplasty
Time frame: 3 months after surgery
Graft uptake rate was assessed by otoscopic examination. A successful graft uptake was defined as an intact and correctly positioned graft with closure of the tympanic membrane perforation, without evidence of graft rejection or active infection.
1 secondary outcome
Complete Air-Bone Gap Closure
Time frame: 3 months after surgery
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 19 May 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. This study is not recruiting at the moment.
Hafiz Adil Ikram principal investigator
Shaikh Zayed Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet Temporalis Fascia Graft Tympanoplasty and Dry Temporalis Fascia Graft 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 7 inclusion and 8 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 19 May 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 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 after tympanoplasty (time frame: 3 months after surgery). The study lists 2 primary outcomes in all. 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 19 May 2026.