Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

Tympanic Membrane Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569969
• Other study ID #: Ir.bmsu.rec.1395.233
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: June 2018
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

Procedure:
• device: Tympanoplasty with Membrane Amniotic
amniotic membrane Tympanoplasty
• Tympanoplasty With Autologous Fascia
Autologous Temporalis fascia Tympanoplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad Sadegh Bagheri Baghdasht

References & Publications (8)

Catalano GB, Conticello S. [The long-term results of myringoplasty with amnion graft]. Otorinolaringologie. 1969 Apr-Jun;14(2):97-102. Romanian. — View 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. — View 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. — View Citation

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

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. — View Citation

Rao TV, Chandrasekharam V. Use of dry human and bovine amnion as a biological dressing. Arch Surg. 1981 Jul;116(7):891-6. — View Citation

Silveira FC, Pinto FC, Caldas Neto Sda S, Leal Mde C, Cesário 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity and surgical complications	Signs and symptoms that are unexpectedly followed by surgery	Up to 1 year
Primary	The amount of restoration	Restoration of tympanic membrane	Up to 1 year
Primary	Duration of hospitalization	From the time of acceptance of the discharge	24 hour