Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

Not Applicable

Completed

• Conditions: Tympanic Membrane Perforation
• Interventions: Procedure: Tympanoplasty With Autologous Fascia

• Registration Number: NCT03569969
• Lead Sponsor: Mohammad Sadegh Bagheri Baghdasht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-12-01
• Study First Submitted: 2018-01-11
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-24
• Study First Posted: 2018-06-26
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Tympanoplasty With Autologous Fascia	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.

Primary Outcome Measures

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