Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
NCT ID: NCT06542367
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-01
2026-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* The tympanic membrane perforation edges are not accessible/visualized transcanal
* Pregnancy
* Allergy to lidocaine
18 Years
99 Years
ALL
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Yoni Evgeni Gutkovich
Doctor
Central Contacts
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Other Identifiers
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0047-24-EMC
Identifier Type: -
Identifier Source: org_study_id
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