Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A: Cartilage and Perichondrium
Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone. |
Surgical reconstruction of large or subtotal tympanic membrane perforations using an autologous conchal cartilage graft with attached perichondrium alone. |
|
Experimental: Group B: Cartilage, Perichondrium, and Temporalis Fascia
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Complete Tympanic Membrane Closure
Time Frame: 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. |
6 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cartilage-Fascia Tympanoplasty
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.