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Partial Thickness vs Full Thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty

Outcome of Partial-thickness vs Full-thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty in Adults.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07471191
Enrollment
30
Registered
2026-03-13
Start date
2026-04-01
Completion date
2028-05-01
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanoplasty Surgery

Brief summary

Primary Objective: Compare 6-month graft success rates between 0.5 mm sliced and 1.8 mm full-thickness tragal cartilage grafts.(3) H1: Sliced cartilage yields ≥90% success versus ≤80% for full-thickness.(3) H0: No difference between arms. Secondary Objectives: * PTA-ABG closure at 6/12 months.(4) * Speech discrimination score improvement.(4) * Operative time.(6)

Detailed description

chronic suppurative otitis media with tympanic membrane perforation impacts a large number of adults worldwide, more in rural Upper Egypt due to recurrent infections.(1) These perforations cause ongoing ear discharge, hearing impairment, quality-of-life decline, and increased healthcare costs.(1) Conventional temporalis fascia grafting achieves 80-90% success in small defects but drops below 70% for subtotal/large perforations (\>50%tympanic membrane area) or with Eustachian tube issues.(2) Tragal cartilage grafting offers superior durability, with meta-analyses showing 92-98% closure rates versus 82-88% for fascia graft .(3) Full-thickness cartilage (\>1.5 mm), however, risks acoustic mass-loading, worsening high-frequency hearing by 8-12 dB at 4 kHz.(4) Partial-thickness slicing (0.4-0.6 mm) maintains strength while enhancing sound transmission, as shown in clinical series.(5) Endoscopic approaches further improve visualization and reduce operative trauma.(6) No randomized trials compare sliced versus full-thickness tragal cartilage in adult endoscopic tympanoplasty.(7,8) This pilot study fills that gap, optimizing technique for local needs before

Interventions

DEVICEendoscope

endoscopic type 1 tympano plasty

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-65 years. * safe chronic perforation ≥6 months. * Subtotal (25-75%) or large (\>75%) pars tensa defect. * Dry ear ≥3 months (culture-negative). * Intact ossicles, healthy mucosa. * Viable tragal cartilage. * Informed written consent capability.

Exclusion criteria

* unsafe otitis, * active discharge, * Eustachian dysfunction e.g cleft palate, * ossicular defects * prior surgery, * unfit patients * non-compliance

Design outcomes

Primary

MeasureTime frameDescription
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.baselineOutcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.

Contacts

CONTACTMonica Gamil Tawfiq
gamilmonica25@gmail.com01270882995
CONTACTEzzat Mohamed Saleh, Prof
ezzatsaleh@aun.edu.eg01006722404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026