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NCT Number: NCT07471191

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

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)

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscope

Device

endoscopic type 1 tympano plasty

Other names: tympanoplasty

Primary outcomes

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

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ezzat Mohamed Saleh, Prof

CONTACT

[email protected]

01006722404

Monica Gamil Tawfiq

CONTACT

[email protected]

01270882995

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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