Cholesteatoma (acquired or congenital) of moderate to severe grade
Conditions
Interventions
Blood tests and blood collection for preparing autologous serum for cell cultures
Skin incision and harvesting part of the auricular cartilage
Placement of tissue-engineered cartilage after mastoidect
Sponsors
Ito Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 20-69 years old (both at informed consent and at surgery) 2. Patient with cholesteatoma (acquired or congenital) of moderate to severe grade 3. Patient from whom written informed consent is acquired for participating in the present clinical research
Exclusion criteria
Exclusion criteria: 1. Continuous otorrhea caused by MRSA, multi-drug resistant Pseudomonas aeruginosa, etc. 2. When anticoagulant drugs cannot be discontinued 3. Diabetes mellitus with poor control 4. Severe disorder in circulatory, respiratory, hepatic, renal, or hematologic organs 5. Severe allergic disease 6. Inability to use post-operative antibiotics because of drug allergy 7. Malignant disease in internal organs, blood, etc. (excluding completely cured one) 8. Addict of narcotic drugs, alcohol, etc. 9. Other complications that may increase susceptibility to infection 10. Participation in other clinical studies or trials, presently or during 6 months before informed consent 11. Pregnancy or breast-feeding presently, or women who do not agree with anticonception through 6 months after surgery 12. Possibility of syphilis, hepatitis B, hepatitis C, human immunodeficiency virus infection, or human T cell leukemia virus infection 13. Present or past affection, including members of family, of autoimmune disease, such as rheumatic arthritis, psoriatic arthritis, systemic lupus erythematodes, discoid lupus erythematodes, dermatomyositis, polymyositis, chronic thyroiditis, Basedow's disease, polyarteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter's syndrome, mixed connective tissue disease, and relapsing polychondritis 14. History or possibility of hypersensitivity or allergy to collagen preparation, lactic acid-based polymer preparation, fibroblast growth factor (FGF) preparation, insulin preparation, penicillin, streptomycin, amphotericin B, or dexamethasone 15. Use, within 3 months of autologous blood donation, of FGF-2 preparation, parathormone (PTH) preparation, insulin-like growth factor-I (IGF-I) preparation, insulin preparation, growth hormone preparation, female sex hormone preparation (except cosmetics), male hormone preparation, IL-1 receptor antagonist preparation, thyroid hormone preparation, vitamin D preparation (except supplements), or steroid preparation (except medicine for external application) 16. Positive result of intracutaneous test for atelocollagen 17. Others judged inappropriate by the doctors in charge of the study 18. History of hypersensitivity to the ingredient of Beriplast (fibrin glue) or to preparations using cow lungs raw materials (aprotinin, etc.) 19. Present treatment with coagulation accelerator (snake poison preparation), antifibrinolytic agent, or aprotinin preparation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retraction of external auditory canal evaluated by CT at 6 months after surgery, compared to the state at 3 months after surgery. (criterion: preservation of 65% or more at 6 months compared to 100% at 3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection and necrosis of the implanted cartilage (excluding that caused by recurrence of cholesteatoma) | — |
Countries
Japan
Contacts
Public ContactKen Ito
Teikyo University School of Medicine
Outcome results
None listed