An interventional study of Conchal Cartilage and Perichondrium Tympanoplasty and Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty in Tympanic Membrane Perforation, Otitis Media and Suppurative Otitis Media, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer of temporalis fascia over the cartilage graft improves anatomical closure and functional hearing.
The primary purpose of this study is to determine whether adding a temporalis fascia layer to a conchal cartilage and perichondrium graft improves graft healing rates and audiological outcomes in patients undergoing tympanoplasty for large or subtotal perforations.
Adult participants with safe chronic suppurative otitis media and large or subtotal tympanic membrane perforations are randomly assigned in a 1:1 ratio to one of two surgical arms:
All participants undergo clinical otomicroscopy/otoendoscopy to assess graft take, healing, and complications, alongside pure-tone audiometry (evaluating air-bone gap and hearing thresholds) preoperatively and at 6 months postoperatively.
53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.
This study's planned enrollment of 50 is below the median of 57 across 39 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
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Exclusion Criteria:
Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone.
Procedure: Conchal Cartilage and Perichondrium Tympanoplasty
Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium combined with an additional temporalis fascia layer placed outside the cartilage graft between the cartilage and the tympanic membrane remnant.
Procedure: Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty
Surgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage graft with attached perichondrium alone.
Surgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage and perichondrium graft combined with an additional layer of temporalis fascia positioned outside the cartilage graft between the cartilage and the tympanic membrane remnant.
Rate of Complete Tympanic Membrane Closure
Evaluated by otomicroscopic or otoendoscopic examination. Complete closure is defined as an intact graft with total epithelialization and closure of the tympanic membrane perforation, with no residual or recurrent perforation.
Time frame: 6 months postoperatively
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Tympanic Membrane Perforation →