Clinical trial NCT05967845: Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty
Official title: Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Suppurative Otitis Media
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Healing rate, or graft take rate.
timeFrame: 12 weeks
Secondary outcomes:
measure: Hearing outcomes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University faculty of Medicine
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Hisham A Ebada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.