Tympanic Membrane PerforationNCT07913087
Effect of Autologous Serum-Soaked Paper Patch vs. Traditional Dry Paper Patch on Tympanic Membrane Perforations
A study testing Autologous Serum-Soaked Paper Patch Myringoplasty and Conventional Dry Paper Patch Myringoplasty in people with Tympanic Membrane Perforation, run by Rawalpindi Medical College.
Trial summary
This randomized controlled trial evaluates whether an autologous serum-soaked paper patch improves complete tympanic membrane closure rates at 8 weeks compared to a traditional dry paper patch in patients with small dry tympanic membrane perforations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Autologous Serum-Soaked Paper Patch Myringoplasty and Conventional Dry Paper Patch Myringoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 31 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-60 years.
- Small dry tympanic membrane perforation (≤1 quadrant).
- Dry perforation present for ≥3 months duration.
- No active discharge or middle ear infection.
- Conductive hearing loss confirmed on pure tone audiometry.
Who cannot join
- Perforation involving >1 quadrant of the tympanic membrane.
- History of previous ear surgery.
- Clinical or radiological evidence of cholesteatoma.
- Ossicular chain pathology suspected clinically.
- Uncontrolled diabetes mellitus.
- Bleeding disorders or anticoagulant use.
- Pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Autologous Serum-soaked Paper Patch Compared With Traditional Dry Paper Patch on the Healing Outcomes of Patients With Small Dry Perforations of the Tympanic Membrane: a Randomized Controlled Trial
This randomized controlled trial evaluates whether an autologous serum-soaked paper patch improves complete tympanic membrane closure rates at 8 weeks compared to a traditional dry paper patch in patients with small dry tympanic membrane perforations.
Read the detailed description
Tympanic membrane perforations are a common otological condition causing conductive hearing loss and recurrent ear infections. While paper patching is a cost-effective outpatient treatment, traditional dry paper patches show inconsistent success rates. Autologous serum contains growth factors and cytokines that promote wound healing and tissue regeneration.
This single-blind, parallel-group randomized controlled trial will enroll 74 patients (37 per arm) presenting with small dry tympanic membrane perforations (≤1 quadrant, present for ≥3 months) at Rawalpindi Teaching Hospital. Following 50% trichloroacetic acid edge cautery, participants will be randomized 1:1 to receive either an autologous serum-soaked Whatman Grade 1 paper patch or a dry paper patch without using any biological agent.
The primary outcome is the rate of complete tympanic membrane closure confirmed via otomicroscopy at 8 weeks. Secondary outcomes include time to complete closure assessed during scheduled follow-up visits (Weeks 2, 4, and 8) and hearing improvement determined through pure tone audiometry.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Autologous Serum-Soaked Paper Patch Myringoplasty, Conventional Dry Paper Patch Myringoplasty
- Keywords
- Autologous serum, Paper patch myringoplasty, Eardrum 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.
Autologous Serum-Soaked Paper Patch MyringoplastyProcedure or surgery
Also called Myringoplasty
Venous blood centrifuged at 3000 rpm for 10 minutes to harvest serum. Whatman Grade 1 filter paper is saturated with serum for 2 minutes and applied over the perforation following chemical cauterization of Tympanic Membrane margins with 50% trichloroacetic acid.
Conventional Dry Paper Patch MyringoplastyProcedure or surgery
Also called Myringoplasty
Sterile Whatman Grade 1 filter paper applied dry over the perforation following 50% trichloroacetic acid edge cautery.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Serum-Soaked Paper Patch Group | Experimental | Patients will receive an autologous serum-soaked Whatman Grade 1 paper patch applied over the tympanic membrane perforation after 50% trichloroacetic acid edge cautery. Receives: Procedure: Autologous Serum-Soaked Paper Patch Myringoplasty |
| Traditional Dry Paper Patch Group | Active comparator | Patients will receive a conventional dry Whatman Grade 1 paper patch applied over the tympanic membrane perforation after 50% trichloroacetic acid edge cautery. Receives: Procedure: Conventional Dry Paper Patch Myringoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Closure of Tympanic Membrane Perforations
Total absence of membrane defect on otomicroscopy, confirmed by an ENT physician masked to treatment allocation.
Measured: 8 weeks
Secondary outcomes (2)
Time to Complete Closure of Tympanic Membrane Perforations
Number of days between the first patching and the first reported complete membrane re-epithelialization assessed at scheduled otomicroscopy follow-up visits.
Measured: Up to 8 weeks
Change in Hearing Levels (Pure Tone Audiometry)
Difference in pure tone average (air-conduction threshold at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz) before treatment and at 8 weeks, performed by a certified, treatment-masked audiologist.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 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.
- 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
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ali Javed, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913087
- Sponsor's protocol ID
- 2024/RTH, RWP.
- Other IDs
- ENT-2025-126-1774
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Serum-soaked Paper Patch Compared With Traditional Dry Paper Patch on the Healing Outcomes of Patients With Small Dry Perforations of the Tympanic Membrane: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07913087
- Acronym / sponsor ID
- 2024/RTH, RWP.
- Conditions
- Tympanic Membrane Perforation
- Keywords
- Autologous serum, Paper patch myringoplasty, Eardrum perforation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 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 randomized controlled trial evaluates whether an autologous serum-soaked paper patch improves complete tympanic membrane closure rates at 8 weeks compared to a traditional dry paper patch in patients with small dry tympanic membrane perforations.
Detailed description
Tympanic membrane perforations are a common otological condition causing conductive hearing loss and recurrent ear infections. While paper patching is a cost-effective outpatient treatment, traditional dry paper patches show inconsistent success rates. Autologous serum contains growth factors and cytokines that promote wound healing and tissue regeneration.
This single-blind, parallel-group randomized controlled trial will enroll 74 patients (37 per arm) presenting with small dry tympanic membrane perforations (≤1 quadrant, present for ≥3 months) at Rawalpindi Teaching Hospital. Following 50% trichloroacetic acid edge cautery, participants will be randomized 1:1 to receive either an autologous serum-soaked Whatman Grade 1 paper patch or a dry paper patch without using any biological agent.
The primary outcome is the rate of complete tympanic membrane closure confirmed via otomicroscopy at 8 weeks. Secondary outcomes include time to complete closure assessed during scheduled follow-up visits (Weeks 2, 4, and 8) and hearing improvement determined through pure tone audiometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Serum-Soaked Paper Patch Group | Experimental | Procedure: Autologous Serum-Soaked Paper Patch MyringoplastyPatients will receive an autologous serum-soaked Whatman Grade 1 paper patch applied over the tympanic membrane perforation after 50% trichloroacetic acid edge cautery. |
| Traditional Dry Paper Patch Group | Active comparator | Procedure: Conventional Dry Paper Patch MyringoplastyPatients will receive a conventional dry Whatman Grade 1 paper patch applied over the tympanic membrane perforation after 50% trichloroacetic acid edge cautery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18-60 years.
- Small dry tympanic membrane perforation (≤1 quadrant).
- Dry perforation present for ≥3 months duration.
- No active discharge or middle ear infection.
- Conductive hearing loss confirmed on pure tone audiometry.
Key exclusion criteria (7 listed)
- Perforation involving >1 quadrant of the tympanic membrane.
- History of previous ear surgery.
- Clinical or radiological evidence of cholesteatoma.
- Ossicular chain pathology suspected clinically.
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| Autologous Serum-Soaked Paper Patch MyringoplastyAlso: MyringoplastyVenous blood centrifuged at 3000 rpm for 10 minutes to harvest serum. Whatman Grade 1 filter paper is saturated with serum for 2 minutes and applied over the perforation following chemical cauterization of Tympanic Membrane margins with 50% trichloroacetic acid. | Procedure or surgery | Autologous Serum-Soaked Paper Patch Group |
| Conventional Dry Paper Patch MyringoplastyAlso: MyringoplastySterile Whatman Grade 1 filter paper applied dry over the perforation following 50% trichloroacetic acid edge cautery. | Procedure or surgery | Traditional Dry Paper Patch Group |
Primary outcome
Rate of Complete Closure of Tympanic Membrane Perforations
Time frame: 8 weeks
Total absence of membrane defect on otomicroscopy, confirmed by an ENT physician masked to treatment allocation.
2 secondary outcomes
Time to Complete Closure of Tympanic Membrane Perforations
Time frame: Up to 8 weeks
Change in Hearing Levels (Pure Tone Audiometry)
Time frame: Baseline and 8 weeks
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Serum-Soaked Paper Patch Myringoplasty and Conventional Dry Paper Patch Myringoplasty in people with Tympanic Membrane Perforation, run by Rawalpindi Medical College.
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 5 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: opening soon, as of the sponsor's last update on 5 Nov 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?
Contact Muhammad Ali Javed, MBBS (03295718202, ajaved123886@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Closure of Tympanic Membrane Perforations (time frame: 8 weeks). 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 5 Nov 2026.