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

Launched by HAEMEK MEDICAL CENTER, ISRAEL · Aug 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called trans canal tympanoplasty, which is used to repair holes in the eardrum, known as tympanic membrane perforations. The researchers want to see how effective this procedure is when performed under local anesthesia using a fat graft and a special product called "TachoSil." The goal is to help improve hearing and heal the eardrum in people who have had a perforation for more than six months.

To participate in this study, individuals must be between 6 and 75 years old and have specific criteria, such as a chronic hole in their eardrum and a certain level of hearing loss. Participants will undergo the procedure and then be followed for a year, during which they will have regular check-ups and hearing tests to monitor their recovery. It's important to note that not everyone will qualify; for example, people with certain ear conditions or allergies may be excluded. The trial is not yet recruiting participants but aims to provide valuable information on how this surgical approach can help those with eardrum problems.

Gender

ALL

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