Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Tympanic Membrane Perforation

Intervention / Treatment
-----------------
* Procedure: device: Tympanoplasty with Membrane Amniotic
* Procedure: Tympanoplasty With Autologous Fascia


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>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. | Procedure: Tympanoplasty With Autologous Fascia<br>* Autologous Temporalis fascia Tympanoplasty<br>|
| Experimental: Test group<br>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. | Procedure: device: Tympanoplasty with Membrane Amniotic<br>* amniotic membrane Tympanoplasty<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amniotic membrane, Tympanic Membrane Perforation