NCT05967845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

4 years

First QC Date

June 29, 2023

Last Update Submit

July 22, 2023

Conditions

Chronic Suppurative Otitis Media

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Hearing outcomes

    12 weeks

Study Arms (2)

Platelet rich fibrin augmented tympanoplasty

ACTIVE COMPARATOR

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

cartilage tympanoplasty

ACTIVE COMPARATOR

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

Procedure: cartilage tympanoplasty

Interventions

cartilage tympanoplastyPROCEDURE

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

cartilage tympanoplasty
platelet rich fibrin augmented tympanoplastyPROCEDURE

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.

Platelet rich fibrin augmented tympanoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults patients older than 18 years.
  • Chronic suppurative otitis media mucosal type with total or subtotal perforation.
  • Inactive for 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University faculty of Medicine

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 36032890RESULT

  • 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.

    PMID: 29576202RESULT

  • 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.

    PMID: 31735178RESULT

Study Officials

  • Hisham A Ebada, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2023

First Posted

August 1, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)