NCT06542367

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tympanic Membrane Perforation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2024-08-07
• Last updated: 2024-08-13