About this trial
This study aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital conditions (like microtia, a condition where the ear is underdeveloped), trauma (such as dog bites), or surgical resections secondary to skin cancer. The investigators have developed a novel medical device to shape cartilage into pre-determined shapes that, once assembled, assists the surgeon in creating an anatomically accurate cartilaginous ear framework, reduce surgery time, and minimize wire need. Other factors that might affect the quality of surgical outcomes will be examined in clinical trial participants.
Eligibility criteria
Qualifiers
Patients aged 5-20 years seeking to undergo surgical ear reconstruction or microtia repair under general anesthesia through NCH-FL
Pre-existing physical deformity of the ear necessitating surgical reconstruction
Patient of sufficient health to undergo surgery under general anesthesia
Parental or legally acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate
Disqualifiers
Patients who will be ≤4 years old, or ≥21 years old at time of surgery
Patients with ear deformities do not require surgical correction
Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida
Patients determined to be in poor health to undergo surgery under general anesthesia
Trial design
Treatments tested in this trial
- Use of AuryzoN™ EAR 2.0 device
- Hand carving