Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Mansoura University

Status: Completed

Conditions: Chronic Suppurative Otitis Media

Treatments: Procedure: platelet rich fibrin augmented tympanoplasty; Procedure: cartilage tympanoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05967845

MS.19.04.576

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

156 participants in 2 patient groups

Platelet rich fibrin augmented tympanoplasty

Active Comparator group

Description:

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.

Treatment:

Procedure: platelet rich fibrin augmented tympanoplasty

cartilage tympanoplasty

Active Comparator group

Description:

A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty

Treatment:

Procedure: cartilage tympanoplasty