Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty: a Randomized Clinical Trial

Conditions
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Chronic Suppurative Otitis Media

Intervention / Treatment
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* Procedure: cartilage tympanoplasty
* Procedure: platelet rich fibrin augmented tympanoplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelet rich fibrin augmented tympanoplasty<br>Platelet rich fibrin will be prepaired from the patient's own blood throud a centrifugation process and will be applied on the temproalis fascia graft to improve healing. | Procedure: platelet rich fibrin augmented tympanoplasty<br>* 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.<br>|
| Active Comparator: cartilage tympanoplasty<br>A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty | Procedure: cartilage tympanoplasty<br>* cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing outcomes | Postoperative changes of hearing levels as assessed by pure tone audiometry. | 12 weeks |