Chronic Suppurative Otitis Media
Conditions
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.
Interventions
PROCEDUREcartilage tympanoplasty
cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.
PROCEDUREplatelet rich fibrin augmented tympanoplasty
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hearing outcomes | 12 weeks | Postoperative changes of hearing levels as assessed by pure tone audiometry. |
Countries
Egypt
Outcome results
None listed