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Completed

NCT Number: NCT05967845

Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

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.

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Key information

Conditions

Chronic Suppurative Otitis Media

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University faculty of Medicine

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cartilage tympanoplasty

Procedure

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

platelet rich fibrin augmented tympanoplasty

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.

Primary outcomes

  1. Healing rate, or graft take rate.

    Time frame: 12 weeks

    Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.

Secondary outcomes

  1. Hearing outcomes

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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