Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT05967845

Collaborator

(none)

156

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Suppurative Otitis Media	Procedure: cartilage tympanoplasty Procedure: platelet rich fibrin augmented tympanoplasty	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Hearing outcomes [12 weeks]
Postoperative changes of hearing levels as assessed by pure tone audiometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University faculty of Medicine	Mansoura	Dakahlia	Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Hisham A Ebada, MD, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hisham Ebada, Assistant Professor, Mansoura University

ClinicalTrials.gov Identifier:

NCT05967845

Other Study ID Numbers:

MS.19.04.576

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Otitis Media, Suppurative

Otitis Media

Study Results

No Results Posted as of Aug 1, 2023