Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft

March 23, 2021 updated by: Caroleen Mounir Tawfik, Assiut University
Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

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

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years

Exclusion Criteria:

  1. active infection
  2. sensorineural hearing loss
  3. compromised immune system 4 - patients age below 18 years

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
Time Frame: 1 year
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hamza Elshafie, Professor, Assiut University

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, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Cartilage tympanoplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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