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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of Complete Tympanic Membrane Closure
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Cartilage-Fascia Tympanoplasty
Läkemedels- och apparatinformation, studiedokument
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