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

HaEmek Medical Center, Israel

Status: Not yet enrolling

Conditions: Tympanic Membrane Perforation

Treatments: Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".

Study type: Interventional

Funder types: Other

Identifiers

NCT06542367

0047-24-EMC

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"

Experimental group

Description:

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

Treatment:

Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".