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NCT05282810 Clinical Trial

Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''

Tympanic Membrane Perforation Clinical Trial

Official title:
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05282810
Other study ID # recurrent tympanoplasty
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2022
Est. completion date May 2023

Study information
Verified date March 2022
Source Assiut University
Contact caroleen mounir, researcher
Phone 01206045590
Email caroleenmounir@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation

Description:

The main aim of successful tympanoplasty is to create a well aerated closed cavity after total removal of the disease. Numerous types of grafting materials have been used for closure of the tympanic membrane including fascia, periosteum, perichondrium, cartilage, vein, skin, and fat tissue . Autografts are thought to be the most compatible grafting materials with the best surgical results in tympanoplasty Temporal muscle fascia is composed of irregularly arranged elastic fibers and fibrous connective tissue. For this reason postoperative dimensions of temporal muscle fascia are unpredictable. Cartilage has a constant shape, firmer than fascia and also lack fibrous tissue, so that postoperative dimensions remains the same and beside this, it is also nourished by diffusion and show great adaptation with TM . These advantages make the cartilage graft more preferable by otologists recently. the use of cartilage graft in many different ways such as perichondrium cartilage island technique, palisade technique or cartilage reinforcement technique

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 26
Est. completion date May 2023
Est. primary completion date April 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss Exclusion Criteria: - sensorineural hearing loss active infection compromised immune system

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• tympanoplasty
use of cartilage versus tempotalis fascia in tympanoplasty for recuurent perforation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Jalali MM, Motasaddi M, Kouhi A, Dabiri S, Soleimani R. Comparison of cartilage with temporalis fascia tympanoplasty: A meta-analysis of comparative studies. Laryngoscope. 2017 Sep;127(9):2139-2148. doi: 10.1002/lary.26451. Epub 2016 Dec 9. Review. — View Citation

Shakya D, Nepal A. Long-term results of type I tympanoplasty with perichondrium reinforced cartilage palisade vs temporalis fascia for large perforations: A retrospective study. J Otol. 2021 Jan;16(1):12-17. doi: 10.1016/j.joto.2020.07.004. Epub 2020 Jul 29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study '' compare of improvment of hearing by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation compare of graft take up by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation Baseline
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