Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Tympanic Membrane Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Tympanoplasty With Autologous Fascia

Intervention Type PROCEDURE

Autologous Temporalis fascia Tympanoplasty

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.

Group Type EXPERIMENTAL

device: Tympanoplasty with Membrane Amniotic

Intervention Type PROCEDURE

amniotic membrane Tympanoplasty

Interventions

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device: Tympanoplasty with Membrane Amniotic

amniotic membrane Tympanoplasty

Intervention Type PROCEDURE

Tympanoplasty With Autologous Fascia

Autologous Temporalis fascia Tympanoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes