AuriNovo for Auricular Reconstruction

Exclusion Criteria

• •1. Previous cochlear implant surgery
• •2. Patients with prior surgery in the temporal, parietal, or mastoid regions of the affected side that resulted in scarring that may affect the outcome of microtia reconstruction surgery.
• •3. Sensitivity to broad-spectrum aminoglycoside antibiotics containing any of the following: streptomycin, gentamycin tobramycin, amikacin, kanamycin, neomycin, or plazomicin.
• •4. Sensitivity to materials of porcine origin including pork products. For subjects with no known exposure to porcine materials including pork products, sensitivity as confirmed at baseline through a positive porcine skin sensitivity test.
• •5. Patients previously diagnosed/evaluated for any of the following syndromes:
• •1. CHARGE (Coloboma, Heart defect, choanal Atresia, Retarded growth and development, Genital hypoplasia, Ear anomalies) syndrome,
• •2. Branchio-oto-renal (BOR) syndrome
• •3. Patients with renal dysfunction of any etiology
• •6. Patients with abnormal renal function determined at baseline with a blood test.
• •7. Patients with a history of keloid formation.
• •8. Patients with current skin infection.
• •9. Patients on immunosuppressants.
• •10. Any cognitive disorders where the patient would not be able to complete subject assessment questionnaires.
• •11. Lifestyle activities likely to affect healing or ability to adhere to the protocol (e.g., active contact sports and protective gear interferes with wearing post-operative ear protection)
• •12. Patients requiring chronic use of any headgear (e.g., CPAP) that would interfere with the ability to wear post-operative ear protection.
• •13. Pregnant females (a negative pregnancy test is required for females with reproductive potential)
• •14. Female patients who are nursing/lactating
• •15. Patients of reproductive potential (male and female) unwilling to use effective contraception during the first post-operative year.
• •For this first-in-human study, microtia patients with significant craniofacial asymmetries or deformities from other syndromes will be excluded in order to aid initial assessments of efficacy of AuriNovo. The following syndromes or conditions are additional exclusion factors:
• •16. Treacher-Collins Syndrome
• •17. Nager Syndrome
• •18. Goldenhar syndrome or hemifacial microsomia plus an occlusal cant of 20 degrees or greater
• •19. Absence of vertical ramus (as diagnosed on physical exam or CT)
• •20. Absence of zygoma (as diagnosed on physical exam or CT)
• •21. Significant orbital asymmetry or micro-ophthalmia (as diagnosed on physical exam or CT)