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Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Primary Purpose

Chronic Suppurative Otitis Media

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cartilage tympanoplasty
platelet rich fibrin augmented tympanoplasty
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Suppurative Otitis Media

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Platelet rich fibrin augmented tympanoplasty

cartilage tympanoplasty

Arm Description

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.

A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hearing outcomes
Postoperative changes of hearing levels as assessed by pure tone audiometry.

Full Information

First Posted
June 29, 2023
Last Updated
July 22, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05967845
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Suppurative Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich fibrin augmented tympanoplasty
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cartilage tympanoplasty
Arm Type
Active Comparator
Arm Description
A piece of cartilage will be harvested from the concha and used as a graft for tympanoplasty
Intervention Type
Procedure
Intervention Name(s)
cartilage tympanoplasty
Intervention Description
cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.
Intervention Type
Procedure
Intervention Name(s)
platelet rich fibrin augmented tympanoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing rate, or graft take rate.
Description
Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hearing outcomes
Description
Postoperative changes of hearing levels as assessed by pure tone audiometry.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham A Ebada, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University faculty of Medicine
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36032890
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.
Results Reference
result
PubMed Identifier
29576202
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.
Results Reference
result
PubMed Identifier
31735178
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.
Results Reference
result

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Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

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