An interventional study of Tympanoplasty performed under local anesthesia using fat graft and "Tachosil". in Tympanic Membrane Perforation, sponsored by HaEmek Medical Center, Israel. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Treatment
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.
53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.
This study's planned enrollment of 20 is below the median of 57 across 39 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Tympanic Membrane Perforation →
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