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

March 10, 2026 updated by: Monica Gamil Tawfiq, Assiut University

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inclusion (all required):

  • 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • grafts in endoscopy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Tympanoplasty Surgery

Clinical Trials on endoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe