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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich fibrin augmented tympanoplasty | Active Comparator | 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. |
|
| cartilage tympanoplasty | Active Comparator | A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cartilage tympanoplasty | Procedure | cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing outcomes | Postoperative changes of hearing levels as assessed by pure tone audiometry. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisham A Ebada, MD | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University faculty of Medicine | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36032890 | Result | Venkatesan D, Umamaheswaran P, Vellikkannu R, Kannan S, Sivaraman A, Ramamurthy S. A Comparative Study of Temporalis Fascia Graft and Full Thickness Tragal Island Cartilage Graft in Type 1 Tympanoplasty. Indian J Otolaryngol Head Neck Surg. 2022 Aug;74(Suppl 1):619-623. doi: 10.1007/s12070-021-02459-2. Epub 2021 Feb 19. | |
| 29576202 |
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| platelet rich fibrin augmented tympanoplasty | Procedure | 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. |
|
| Jain A, Samdani S, Sharma MP, Meena V. Island cartilage vs temporalis fascia in type 1 tympanoplasty: A prospective study. Acta Otorrinolaringol Esp (Engl Ed). 2018 Nov-Dec;69(6):311-317. doi: 10.1016/j.otorri.2017.10.004. Epub 2018 Mar 22. English, Spanish. |
| 31735178 | Result | Gokce Kutuk S, Ozdas T. Impact of platelet-rich fibrin therapy in tympanoplasty type 1 surgery on graft survival and frequency-specific hearing outcomes: a retrospective analysis in patients with tympanic membrane perforation due to chronic otitis media. J Laryngol Otol. 2019 Dec;133(12):1068-1073. doi: 10.1017/S0022215119002391. Epub 2019 Nov 18. |