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:
* Group A:Tympanoplasty using an autologous conchal cartilage graft with attached perichondrium alone. * Group B: Tympanoplasty using an autologous conchal cartilage and perichondrium graft reinforced with an additional outer layer of temporalis fascia placed between the cartilage and the tympanic membrane remnant.
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.
Age 18 years and older
Presence of a large or subtotal tympanic membrane perforation
Safe chronic suppurative otitis media (CSOM)
Undergoing primary or revision tympanoplasty
Unsafe ear (e.g., presence of cholesteatoma, marginal perforation, or attic pathology)
Small or medium-sized tympanic membrane perforations
Age younger than 18 years
Patients unwilling or unable to attend scheduled postoperative follow-up visits through 6 months
Parallel
Conchal Cartilage and Perichondrium Tympanoplasty
Procedure/SurgerySurgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage graft with attached perichondrium alone.
Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty
Procedure/SurgerySurgical 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.
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