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NCT Number: NCT06542367

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

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.

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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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 outcomes

  1. closure of tympanic membrane perforation

    Time frame: 1 year following the procedure

    the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.

Secondary outcomes

  1. Hearing results following tympanoplasty - Speech recognition threshold

    Time frame: 1 year following the procedure

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

  2. Hearing results following tympanoplasty - Pure Tone Average

    Time frame: 1 year following the procedure

    PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.

  3. Hearing results following tympanoplasty - air bone gap.

    Time frame: 1 year following the procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lev Shlizerman, M.D

CONTACT

[email protected]

+972-46495563

yoni Evgeni Gutkovich, M.D/Ph.D

CONTACT

[email protected]

+972-46495563

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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