Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?

NCT07834892 — Not applicable, Not yet recruiting, 50 participants, Assiut University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)

Registry	NCT07834892
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Tympanic Membrane Perforation, Otitis Media, Suppurative Otitis Media, Chronic Suppurative Otitis Media
Interventions	Conchal Cartilage and Perichondrium Tympanoplasty, Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty (Procedure)
Dates	start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-09-22, last updated 2026-09-22

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Group A: Cartilage and Perichondrium	Active comparator	Procedure: Conchal Cartilage and Perichondrium Tympanoplasty	Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone.
Group B: Cartilage, Perichondrium, and Temporalis Fascia	Experimental	Procedure: Conchal Cartilage, Perichondrium, and Temporalis Fascia 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.

Conchal Cartilage and Perichondrium Tympanoplasty (Procedure): Surgical 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): 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.

+Outcome measures

Primary outcomes

Rate of Complete Tympanic Membrane Closure [6 months postoperatively]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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