Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Not Applicable

Completed

• Conditions: Chronic Suppurative Otitis Media
• Interventions: Procedure: cartilage tympanoplasty; Procedure: platelet rich fibrin augmented tympanoplasty

• Registration Number: NCT05967845
• Lead Sponsor: Mansoura University

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 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

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-06-29
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-22
• Last Update Submitted: 2023-07-22
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cartilage tympanoplasty	cartilage tympanoplasty	A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty
Platelet rich fibrin augmented tympanoplasty	platelet rich fibrin augmented tympanoplasty	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.

Primary Outcome Measures

Name	Time	Method
Healing rate, or graft take rate.	12 weeks	Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.

Secondary Outcome Measures

Name	Time	Method
Hearing outcomes	12 weeks	Postoperative changes of hearing levels as assessed by pure tone audiometry.

Trial Locations

Locations (1)

Mansoura University faculty of Medicine; 🇪🇬 Mansoura, Dakahlia, Egypt