About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known ossicular chain dysfunction
The tympanic membrane perforation edges are not accessible/visualized transcanal
Pregnancy
Allergy to lidocaine
Trial design
Single group
Treatments tested in this trial
Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".
Procedure/SurgeryUnder 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Hearing results following tympanoplasty - Speech recognition threshold
SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
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.
Hearing results following tympanoplasty - air bone gap.
Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.
Locations
Sponsors and contacts
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