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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHaEmek Medical Center, Israel

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year following the procedure

Secondary outcomes

1

Hearing results following tympanoplasty - Speech recognition threshold

SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.

Time frame
1 year following the procedure
2

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.

Time frame
1 year following the procedure
3

Hearing results following tympanoplasty - air bone gap.

Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.

Time frame
1 year following the procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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