Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Mansoura University156 enrolled

Overview

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 underwent temporalis fascia tympanoplasty, augmented with platelet rich fibrin, while the second group underwent cartilage tympanoplasty. preoperative data, operative techniques, and postoperative outcomes were analyzed.

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 improve healing process. In the cartilage tympanoplasty group, a piece of cartilage is harvested from the patient concha and used for grafting. Both groups will be compared in terms of healing and hearing. Healing is considered successful if an intact tympanic membrane is achieved withing 12 weeks follow up period. Hearing outcomes are analyzed by comparing the preoperative pure tone audiometry values with the postoperative values.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

156

Conditions

Chronic Suppurative Otitis Media

Interventions

cartilage tympanoplastyPROCEDURE

cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.

platelet rich fibrin augmented tympanoplastyPROCEDURE

platelet rich fibrin augmented tympanoplasty entails performing the traditional tympanoplasty using the tempralis fascia as a grafting material. However, platelet rich fibrin clot is obtained from the patient's own blood, and applied to the graft to enhance healing process.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults patients older than 18 years. * Chronic suppurative otitis media mucosal type with total or subtotal perforation. * Inactive for 3 months. Exclusion Criteria: * 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.

Locations (1)

Mansoura University faculty of Medicine

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Healing rate, or graft take rate.

Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.

Time frame: 12 weeks

Secondary Outcomes

Hearing outcomes

Postoperative changes of hearing levels as assessed by pure tone audiometry.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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