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Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

Primary Purpose

Tympanic Membrane Perforation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
device: Tympanoplasty with Membrane Amniotic
Tympanoplasty With Autologous Fascia
Sponsored by
Mohammad Sadegh Bagheri Baghdasht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation focused on measuring amniotic membrane, Tympanic Membrane Perforation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    control group

    Test group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Morbidity and surgical complications
    Signs and symptoms that are unexpectedly followed by surgery
    The amount of restoration
    Restoration of tympanic membrane
    Duration of hospitalization
    From the time of acceptance of the discharge

    Secondary Outcome Measures

    Full Information

    First Posted
    January 11, 2018
    Last Updated
    June 27, 2018
    Sponsor
    Mohammad Sadegh Bagheri Baghdasht
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03569969
    Brief Title
    Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia
    Official Title
    Comparison of Tympanoplasty Surgery Outcome Using Amniotic Membrane and Autologous Temporalis Fascia: A Randomized Clinical Trial Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    June 1, 2017 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohammad Sadegh Bagheri Baghdasht

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tympanic Membrane Perforation
    Keywords
    amniotic membrane, Tympanic Membrane Perforation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    device: Tympanoplasty with Membrane Amniotic
    Intervention Description
    amniotic membrane Tympanoplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Tympanoplasty With Autologous Fascia
    Intervention Description
    Autologous Temporalis fascia Tympanoplasty
    Primary Outcome Measure Information:
    Title
    Morbidity and surgical complications
    Description
    Signs and symptoms that are unexpectedly followed by surgery
    Time Frame
    Up to 1 year
    Title
    The amount of restoration
    Description
    Restoration of tympanic membrane
    Time Frame
    Up to 1 year
    Title
    Duration of hospitalization
    Description
    From the time of acceptance of the discharge
    Time Frame
    24 hour

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26557361
    Citation
    Villar-Fernandez MA, Lopez-Escamez JA. Outlook for Tissue Engineering of the Tympanic Membrane. Audiol Res. 2015 Jan 23;5(1):117. doi: 10.4081/audiores.2015.117. eCollection 2015 Jan 21.
    Results Reference
    background
    PubMed Identifier
    5343906
    Citation
    Catalano GB, Conticello S. [The long-term results of myringoplasty with amnion graft]. Otorinolaringologie. 1969 Apr-Jun;14(2):97-102. No abstract available. Romanian.
    Results Reference
    background
    PubMed Identifier
    16515109
    Citation
    Harvinder S, Hassan S, Sidek DS, Hamzah M, Samsudin AR, Philip R. Underlay myringoplasty: comparison of human amniotic membrane to temporalis fascia graft. Med J Malaysia. 2005 Dec;60(5):585-9.
    Results Reference
    background
    PubMed Identifier
    7259490
    Citation
    Rao TV, Chandrasekharam V. Use of dry human and bovine amnion as a biological dressing. Arch Surg. 1981 Jul;116(7):891-6. doi: 10.1001/archsurg.1981.01380190029007.
    Results Reference
    background
    PubMed Identifier
    26631330
    Citation
    Silveira FC, Pinto FC, Caldas Neto Sda S, Leal Mde C, Cesario J, Aguiar JL. Treatment of tympanic membrane perforation using bacterial cellulose: a randomized controlled trial. Braz J Otorhinolaryngol. 2016 Mar-Apr;82(2):203-8. doi: 10.1016/j.bjorl.2015.03.015. Epub 2015 Sep 8.
    Results Reference
    background
    PubMed Identifier
    20392523
    Citation
    Raj A, Sayal A, Rathore PK, Meher R. Sutureless tympanoplasty using acellular dermis. Am J Otolaryngol. 2011 Mar-Apr;32(2):96-9. doi: 10.1016/j.amjoto.2009.10.007. Epub 2010 Apr 13.
    Results Reference
    background
    Citation
    Hsu, G., Utilizing Dehydrated Human Amnion/Chorion Membrane Allograft in Transcanal Tympanoplasty. Otolaryngology, 2014. 4(161): p. 2.
    Results Reference
    background
    PubMed Identifier
    25667744
    Citation
    Ghanavati SZ, Shousha MA, Betancurt C, Perez VL. Combined conjunctival autograft and overlay amniotic membrane transplantation; a novel surgical treatment for pterygium. J Ophthalmic Vis Res. 2014 Jul-Sep;9(3):399-403. doi: 10.4103/2008-322X.143386. Erratum In: J Ophthalmic Vis Res. 2014 Oct-Dec;9(4):526.
    Results Reference
    background

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    Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

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