Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
Nemours Children's Clinic
Summary
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.
Description
Cartilage-based ear reconstruction addresses congenital anomalies, such as microtia, as well as deformities due to trauma or oncologic resection by replacing like with like tissue. Current technique involves the use of the autologous cartilage as the gold standard and involves harvesting patient's own rib cartilage and carving them into different ear subunits, which are then assembled with numerous steel wires. Challenges of this technique include high operator-dependency due to extensive carving, inconsistent outcomes, prolonged anesthesia, and need for wire or suture fixation, leading to wir…
Eligibility
- Age range
- 5–20 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Sufficient fluency in English or Spanish to complete patient/parent surveys Exclusion Criteria: * Patients who will be ≤4 years old, or…
Interventions
- ProcedureUse of AuryzoN™ EAR 2.0 device
AuryzoN™ 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.
- ProcedureHand carving
Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.
Location
- Nemours Children's Hospital, FloridaOrlando, Florida