Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"

HaEmek Medical Center, Israel0 sites20 target enrollmentSeptember 1, 2024

ConditionsTympanic Membrane Perforation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tympanic Membrane Perforation
Sponsor: HaEmek Medical Center, Israel
Enrollment: 20
Primary Endpoint: closure of tympanic membrane perforation
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Eligible participants with chronic tympanic membrane perforation (>6 month) will be given a detailed description and offered to participate in the study.

the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.

Registry

clinicaltrials.gov

Start Date

September 1, 2024

End Date

September 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

HaEmek Medical Center, Israel

Responsible Party

Principal Investigator

Yoni Evgeni Gutkovich

Doctor

HaEmek Medical Center, Israel

Eligibility Criteria

Inclusion Criteria

•Chronic tympanic membrane perforation (\>6 months).
•Central tympanic membrane perforation.
•Air bone gar of 35 dB or lower at the operated ear.
•No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.
•No evidence of a retraction pocket and no suspicion for a cholesteatoma.

Exclusion Criteria

•Known ossicular chain dysfunction
•The tympanic membrane perforation edges are not accessible/visualized transcanal
•Pregnancy
•Allergy to lidocaine

Outcomes

Primary Outcomes

closure of tympanic membrane perforation

Time Frame: 1 year following the procedure

the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.

Secondary Outcomes

Hearing results following tympanoplasty - Pure Tone Average(1 year following the procedure)
Hearing results following tympanoplasty - Speech recognition threshold(1 year following the procedure)
Hearing results following tympanoplasty - air bone gap.(1 year following the procedure)