Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

NCT03922295

Tympanic Membrane Perforation

COMPLETED NA

Role of Hyaluronic Acid Gel as an Adjunct to Temporalis Facia Graft in Tympanoplasty for Total Tympanic Membrane Perforation

NCT07233226

Tympanoplasty

COMPLETED NA

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

NCT04960384

Tympanic Membrane Perforation

COMPLETED PHASE2

Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

NCT03837665

Tympanic Membrane Perforation

TERMINATED PHASE1/PHASE2

Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

NCT03569969

Tympanic Membrane Perforation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Suppurative Otitis Media

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

platelet rich fibrin augmented tympanoplasty

Intervention Type 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.

cartilage tympanoplasty

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

Group Type ACTIVE_COMPARATOR

cartilage tympanoplasty

Intervention Type PROCEDURE

cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cartilage tympanoplasty

cartilage tympanoplasty procedure entails repairing the tympanic membrane perforation by using a piece of cartilage harvested from the patient's auricle.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No