Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''

March 8, 2022 updated by: Caroleen Mounir Tawfik, Assiut University

Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane

Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main aim of successful tympanoplasty is to create a well aerated closed cavity after total removal of the disease. Numerous types of grafting materials have been used for closure of the tympanic membrane including fascia, periosteum, perichondrium, cartilage, vein, skin, and fat tissue . Autografts are thought to be the most compatible grafting materials with the best surgical results in tympanoplasty Temporal muscle fascia is composed of irregularly arranged elastic fibers and fibrous connective tissue. For this reason postoperative dimensions of temporal muscle fascia are unpredictable.

Cartilage has a constant shape, firmer than fascia and also lack fibrous tissue, so that postoperative dimensions remains the same and beside this, it is also nourished by diffusion and show great adaptation with TM . These advantages make the cartilage graft more preferable by otologists recently.

the use of cartilage graft in many different ways such as perichondrium cartilage island technique, palisade technique or cartilage reinforcement technique

Study Type

Observational

Enrollment (Anticipated)

26

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

  • Name: hamza el shafey ahmed, doctor

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be randomly divided into Group 1, where only temporalis fascia alone will be used as a graft and Group 2, where cartilage will be used along with temporalis fascia graft.

Patients will be followed up and examined at 2 and 6 month to assess

  1. graft take up (healing)
  2. pure tone audiometry( hearing )

Description

Inclusion Criteria:

  • patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss

Exclusion Criteria:

  • sensorineural hearing loss active infection compromised immune system

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cartilage tympanoplasty
use cartilage in tympanoplasty for recuurent perforation
Other: tympanoplasty
use of cartilage versus tempotalis fascia in tympanoplasty for recuurent perforation
temporalis fascia graft in tympanoplasty
use temporalis fascia as a graft in tympanoplasty for recuurent perforation
Other: tympanoplasty
use of cartilage versus tempotalis fascia in tympanoplasty for recuurent perforation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
Time Frame: Baseline
compare of improvment of hearing by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation compare of graft take up by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation
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 (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • recurrent tympanoplasty

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.

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