Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

June 27, 2018 updated by: Mohammad Sadegh Bagheri Baghdasht

Comparison of Tympanoplasty Surgery Outcome Using Amniotic Membrane and Autologous Temporalis Fascia: A Randomized Clinical Trial Study

The tympanic membrane separates the middle and the outer ear from each other and consists of three layers. The outer layer is covered with squamous epithelium, a thick basement membrane in the middle and an inner Mucosal layer. Rupture of the tympanic membrane is common cause of hearing loss.

In spite of the ability to spontaneously healing of the tympanic membrane, chronic tear of the eardrum in the absence of its spontaneously healing indicates surgical management. These surgeries are performing using various materials including fascia, cartilage, fats, pericardium and paper patch. It has proven that using different materials results in outcome and postoperative complications. The criteria of the best graft material includes availability, preservability, manageability, and acceptance rate to the hosts. Human amniotic membrane is preservable. Also, there isn't significant immunologic reactions against such graft material. So, choosing the best graft for Tympanoplasty surgery decreases complications, hospitalizations after surgery, and costs, consequently.

Up to now, limited studies have been conducted on the patients who were used amniotic membrane in the surgical reconstruction. There are different outcomes and complications which depend on the size of the rupture and the problems associated with the surgical conditions.

Considering that it can reduce the surgical time and cost of surgery, and with its high success rate, it can even be used as a substitute for conventional methods. The aim of this study was to compare the result of surgical repair of the tympanic membrane using membrane amniotic and surgical Tympanoplasty with Autologous fascia. Here the investigators reported on 30 patients who underwent Typmanoplasty with amniotic membrane and Temporalis fascia grafting.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • Acute Otorrhea / - Cholesteatomas / - Canal stenosis requiring Canaloplasty / - Immunosuppressive patients / - Active neoplasm / - Diabetes Mellitus / - Ruptures less than one fifth of the eardrum / - Smoking.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control group
Step1. Under local anesthesia and sedation , the temporal muscle fascia was removed, Step2. After the preparation on the tympanic membrane embedded , foam gel smeary with Dexamethasone was worn.Step3. Then the wound dressing was done with a gas number and a Surgifix. Step4. Patients were discharge from the operating room with an oral administration of Cephalexin capsules.
Autologous Temporalis fascia Tympanoplasty
Experimental: Test group
Step1. After sedation and conducting local anesthesia with Lidocaine 2% and inserting the edges of the tympanic membrane and inserting the foam gel into the middle ear, amniotic membranes (produced in Iran tissue product) with a thickness of 100 microns on the tympanic membrane and the foam gel embedded. Step2. Under-layered and short-lived foam gel (manufactured by Ethicon Company) smeary with dexamethasone was covered.
amniotic membrane Tympanoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity and surgical complications
Time Frame: Up to 1 year
Signs and symptoms that are unexpectedly followed by surgery
Up to 1 year
The amount of restoration
Time Frame: Up to 1 year
Restoration of tympanic membrane
Up to 1 year
Duration of hospitalization
Time Frame: 24 hour
From the time of acceptance of the discharge
24 hour

Collaborators and Investigators

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

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 (Actual)

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Ir.bmsu.rec.1395.233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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 Tympanic Membrane Perforation

Clinical Trials on Tympanoplasty With Autologous Fascia

3
Subscribe