Tympanic Membrane Perforation
Conditions
Brief summary
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
Interventions
DRUGfiblast,gelatin sponge,fibrin glue
Sponsors
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed concent obtained 2. At the time of obtaining informed consent, Ages ranged from over 20 to 80 3. At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months (perforation in both ears is excluded)
Exclusion criteria
1. TMP caused by burn or radiation therapy 2. In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry 3. Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity 4. No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge 5. History of tympanoplasty 6. A Part of the eardrum adhered to tympanic cavity 7. By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration) 8. Abnormality in the chain and ear ossicles 9. Air-bone gap difference more than 25dB by patch hearing test 10. Unable to see whole edge of TMP due to narrow external auditory canal 11. Unable to wash out Ear drops during the treatment period 12. Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more) 13. Presenting with autoimmune disease 14. History of malignancy within 3 years prior to obtained informed concent 15. Administration of immunosuppressive agent or anti-cancer-agent 16. History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others 17. Though out the period from screening to treatment, patient who is unable to wash out Thrombolytic agent, Anticoagulant, Anti-platelet agent, Procoagulant agent, anti-line solventandaprotinin formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure of tympanic membrane perforation in the observation period at16 wks | Closure of tympanic membrane perforation in the observation period at16 wks |
Secondary
| Measure | 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 |
| 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 |
Outcome results
None listed