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Not yet recruiting NCT06542367

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

No phase Interventional Tympanic Membrane Perforation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil"..
Who it may be relevant to
Registry conditions: Tympanic Membrane Perforation. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • closure of tympanic membrane perforation [Time frame: 1 year following the procedure]
Secondary outcome measures (3)
  • Hearing results following tympanoplasty - Speech recognition threshold [Time frame: 1 year following the procedure]
  • Hearing results following tympanoplasty - Pure Tone Average [Time frame: 1 year following the procedure]
  • Hearing results following tympanoplasty - air bone gap. [Time frame: 1 year following the procedure]

Eligibility criteria

Inclusion criteria

  • 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.
  • No evidence of a retraction pocket and no suspicion for a cholesteatoma.

Exclusion criteria

  • Known ossicular chain dysfunction
  • The tympanic membrane perforation edges are not accessible/visualized transcanal
  • Pregnancy
  • Allergy to lidocaine

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06542367 · 0047-24-EMC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗