Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

NCT03569969 | Completed DMC

• 1 other identifier: Ir.bmsu.rec.1395.233
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tympanic Membrane Perforation

Keywords

amniotic membrane; Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

control group

EXPERIMENTAL

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

Test group

EXPERIMENTAL

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

Interventions

device: Tympanoplasty with Membrane Amniotic PROCEDURE

amniotic membrane Tympanoplasty

Test group

Tympanoplasty With Autologous Fascia PROCEDURE

Autologous Temporalis fascia Tympanoplasty

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Mohammad Sadegh Bagheri Baghdasht: lead

Related Publications (8)

• 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.

  PMID: 26557361 BACKGROUND

• 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.

  PMID: 5343906 BACKGROUND

• 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.

  PMID: 16515109 BACKGROUND

• 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.

  PMID: 7259490 BACKGROUND

• 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.

  PMID: 26631330 BACKGROUND

• 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.

  PMID: 20392523 BACKGROUND

• Hsu, G., Utilizing Dehydrated Human Amnion/Chorion Membrane Allograft in Transcanal Tympanoplasty. Otolaryngology, 2014. 4(161): p. 2.

  BACKGROUND

• 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.

  PMID: 25667744 BACKGROUND

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

Tympanoplasty

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: June 26, 2018
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06