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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tympanic Membrane Perforation
• Intervention / Treatment: Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yoni Evgeni Gutkovich, M.D/Ph.D; Phone Number: +972-46495563; Email: yonigo@clalit.org.il
• Study Contact Backup: Name: Lev Shlizerman, M.D; Phone Number: +972-46495563; Email: lev_sh@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcanal tympanoplasty under local anasthesia with 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

Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".; 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 to fill the ear canal. follow-up will be held at 2, 4-6 and 12 months following the procedure, with audiometric and otological evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
closure of tympanic membrane perforation	the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.	1 year following the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Tympanoplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 0047-24-EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No