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Clinical Trials/NCT03569969
NCT03569969
Completed
Not Applicable

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

Mohammad Sadegh Bagheri Baghdasht0 sites30 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tympanic Membrane Perforation
Sponsor
Mohammad Sadegh Bagheri Baghdasht
Enrollment
30
Primary Endpoint
The amount of restoration
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 1, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mohammad Sadegh Bagheri Baghdasht
Responsible Party
Sponsor Investigator
Principal Investigator

Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Baqiyatallah Medical Sciences University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

The amount of restoration

Time Frame: Up to 1 year

Restoration of tympanic membrane

Duration of hospitalization

Time Frame: 24 hour

From the time of acceptance of the discharge

Morbidity and surgical complications

Time Frame: Up to 1 year

Signs and symptoms that are unexpectedly followed by surgery

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