Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Suppurative Otitis Media
• Intervention / Treatment: Procedure: platelet rich fibrin augmented tympanoplasty; Procedure: cartilage tympanoplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Mansoura University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelet rich fibrin augmented tympanoplasty; 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.	Procedure: platelet 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.
Active Comparator: cartilage tympanoplasty; A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty	Procedure: cartilage tympanoplasty; cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing outcomes	Postoperative changes of hearing levels as assessed by pure tone audiometry.	12 weeks

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Hisham A Ebada, MD, Mansoura University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 22, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Ear Diseases; Suppuration; Otitis; Otitis Media; Otitis Media, Suppurative
• Other Study ID Numbers: MS.19.04.576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No