Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing results following tympanoplasty - Speech recognition threshold | SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram. | 1 year following the procedure |
| Hearing results following tympanoplasty - Pure Tone Average |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| C518955 | TachoSil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram. |
| 1 year following the procedure |
| Hearing results following tympanoplasty - air bone gap. | Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram. | 1 year following the procedure |