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

NCT07834892 | Not Yet Recruiting

• 1 other identifier: Cartilage-Fascia Tympanoplasty
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tympanic Membrane Perforation; Otitis Media; Suppurative Otitis Media; Chronic Suppurative Otitis Media

Keywords

Tympanoplasty; Cartilage Tympanoplasty; Temporalis Fascia; Conchal Cartilage; Myringoplasty; Air-Bone Gap; Graft Take

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months postoperatively

Study Arms (2)

Group A: Cartilage and Perichondrium

ACTIVE COMPARATOR

Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone.

Procedure: Conchal Cartilage and Perichondrium Tympanoplasty

Group B: Cartilage, Perichondrium, and Temporalis Fascia

EXPERIMENTAL

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

Interventions

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.

Group A: Cartilage and Perichondrium

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.

Group B: Cartilage, Perichondrium, and Temporalis Fascia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Tympanic Membrane Perforation; Otitis Media; Otitis Media, Suppurative

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Otitis; Suppuration; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09