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.
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
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
Parallel
Use of AuryzoN™ EAR 2.0 device
Procedure/SurgeryAuryzoN™ EAR 2.0 is an investigational non-significant risk device developed to improve cartilage construct shape and stability prior to use in ear reconstructive surgery.
Hand carving
Procedure/SurgeryStandard hand carving using standard surgical blades will be performed in this intervention arm of the study.
Evaluate the results of patient and parent satisfaction with the constructed ear's shape and appearance and compare the results between the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort using a four-question survey.
Parents and patients (over age 12) will complete a four-question survey asking how much they like: the shape of the new ear, how the new ear looks, how natural the new ear looks, and the new ear overall. Participants will respond to each question with a rating from 1-5, with 1 being "do not like it at all" and 5 being "like it very much". Investigators will compare the responses from the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort to determine which has more favorable outcomes.
Evaluating reduction in operative time between the two techniques.
Compare changes in operative time between participants enrolled in the AuryzoN™ EAR 2.0 arm and the traditional hand-carving arm.
Evaluating reduction in assembly time between the two techniques.
Compare the assembly time of cartilage into the ear construct between the AuryzoN™ EAR 2.0 arm and the hand-carving technique.
Evaluating reduction in wire usage between the two techniques
Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.
Conduct histopathological analysis assessing outcomes of banked allogeneic cartilage between stage 1 and stage 2 surgeries
Cartilage will be banked in participants' groin or supraclavicular region during the six months between stage 1 and stage 2 ear reconstruction surgeries. Investigators will conduct histopathological analysis to assess the quality of the banked cartilage when it is recovered for use in the stage 2 surgery. This pathological analysis of the banked cartilage will be performed by using Hematoxylin \& Eosin (H\&E) staining and evaluating chondrocytes and extracellular matrix for signs of inflammatory response or rejection.
Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery.
Surgeons will measure the dimensions of the cartilage before banking at the end of the stage 1 surgery and after retrieving the banked cartilage during the stage 2 surgery. Investigators will compare the dimensions of the cartilage before and after banking to determine whether there are any signing or warping or resorption
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