Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Suppurative Otitis Media
- Sponsor
- Mansoura University
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Healing rate, or graft take rate.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Hisham Ebada
Assistant Professor
Mansoura University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Healing rate, or graft take rate.
Time Frame: 12 weeks
Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.
Secondary Outcomes
- Hearing outcomes(12 weeks)