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

Not Applicable

Not yet recruiting

• Conditions: Tympanic Membrane Perforation
• Interventions: Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".

• Registration Number: NCT06542367
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-04
• Study First Posted: 2024-08-07
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Study Start: 2024-09-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"	Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".	eligibale participatns with chronic tympanic membrane perforation will be offered to participate. Under local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the "Tachosil" on top of the fat graft. gelfoam is placed lateral to the tympanic membrane fo fill the ear canal. follow-up will be held at 2, 4-6 and 12 month following the procedure, with audiometric and otological evaluation

Primary Outcome Measures

Name	Time	Method
closure of tympanic membrane perforation	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 Outcome Measures

Name	Time	Method
Hearing results following tympanoplasty - Pure Tone Average	1 year following the procedure	PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Hearing results following tympanoplasty - Speech recognition threshold	1 year following the procedure	SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Hearing results following tympanoplasty - air bone gap.	1 year following the procedure	Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.