Status:
COMPLETED
Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty
Lead Sponsor:
Mansoura University
Conditions:
Chronic Suppurative Otitis Media
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study was performed to compare healing and hearing outcomes of two tympanoplasty techniques, performed for patients with total or subtotal tympanic membrane perforations. The first group underwen...
Detailed Description
Two groups are included. In the platelet rich fibrin augmented tympanoplasty group, a piece of temporalis fascia is harvested and used as a graft material. A layer of platelet rich fibrin is added to ...
Eligibility Criteria
Inclusion
- Adults patients older than 18 years.
- Chronic suppurative otitis media mucosal type with total or subtotal perforation.
- Inactive for 3 months.
Exclusion
- Recurrent perforation after previous tympanoplasty.
- Active inflammation of middle ear.
- Chronic suppurative otitis media epithelial type.
- Ossicular disruption or fixation diagnosed intraoperatively.
- Immunocompromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05967845
Start Date
January 1 2019
End Date
December 31 2022
Last Update
August 1 2023
Active Locations (1)
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1
Mansoura University faculty of Medicine
Al Mansurah, Dakahlia Governorate, Egypt, 35511