An interventional study of Autologous Serum-Soaked Paper Patch Myringoplasty and Conventional Dry Paper Patch Myringoplasty in Tympanic Membrane Perforation, sponsored by Rawalpindi Medical College. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Rawalpindi Medical College · Not applicable, Interventional, and Treatment
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.
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.
53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.
This study's planned enrollment of 74 is above the median of 57 across 39 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →Rawalpindi Medical College is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive an autologous serum-soaked Whatman Grade 1 paper patch applied over the tympanic membrane perforation after 50% trichloroacetic acid edge cautery.
Procedure: Autologous Serum-Soaked Paper Patch Myringoplasty
Patients will receive a conventional dry Whatman Grade 1 paper patch applied over the tympanic membrane perforation after 50% trichloroacetic acid edge cautery.
Procedure: Conventional Dry Paper Patch 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.
Also known as: Myringoplasty
Sterile Whatman Grade 1 filter paper applied dry over the perforation following 50% trichloroacetic acid edge cautery.
Also known as: Myringoplasty
Rate of Complete Closure of Tympanic Membrane Perforations
Total absence of membrane defect on otomicroscopy, confirmed by an ENT physician masked to treatment allocation.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: Baseline and 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tympanic Membrane Perforation →
Rawalpindi Medical College