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To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-18,FBG-18 | Experimental | Intervention drug: NPC-18;trafermin(recombination) and gelatin spnge, combination drug FBG-18;fibrin glue Usage:NPC-18 and FBG-18 is administered at the same time for regenerative treatment of tympanic membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fiblast,gelatin sponge,fibrin glue | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Closure of tympanic membrane perforation in the observation period at16 wks | Closure of tympanic membrane perforation in the observation period at16 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Closure of tympanic membrane perforation in the observation period at 4 wks | Closure of tympanic membrane perforation in the observation period at 4 wks | |
| Improvement of hearing level in the observation period at 4 wks and 16 wks | Improvement of hearing level in the observation period at 4 wks and 16 wks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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| Air-bone gap in the observation period at 4 wks and 16 wks | Air-bone gap in the observation period at 4 wks and 16 wks |
| The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks | The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks |
| Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks | Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks |