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

NCT06542367 | Not Yet Recruiting

• 1 other identifier: 0047-24-EMC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tympanic Membrane Perforation

Keywords

Tympanoplasty

Outcome Measures

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.

  1 year following the procedure

Secondary Outcomes (3)

• Hearing results following tympanoplasty - Speech recognition threshold

  1 year following the procedure

• Hearing results following tympanoplasty - Pure Tone Average

  1 year following the procedure

• Hearing results following tympanoplasty - air bone gap.

  1 year following the procedure

Study Arms (1)

Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"

EXPERIMENTAL

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".

Interventions

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

Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Central Study Contacts

yoni Evgeni Gutkovich, M.D/Ph.D

CONTACT

+972-46495563; yonigo@clalit.org.il

Lev Shlizerman, M.D

CONTACT

+972-46495563; lev_sh@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08