Study of AuryzoN EAR 2.0 Device Versus Hand Carving for Ear Reconstruction Surgery in Children and Young Adults

What this Trial Is About

This research aims to improve surgical results for children and young adults aged 5 to 20 years who have severe ear differences caused by congenital conditions like microtia, injuries such as dog bites, or ear tissue removed due to skin cancer. The study focuses on enhancing ear reconstruction techniques by using a new medical device designed to shape cartilage into precise forms, which helps surgeons create a more accurate ear framework, shortens surgery time, and reduces the need for wires. The study also examines other factors that could influence surgical outcomes. The trial compares two methods of ear reconstruction surgery. One group will have surgery using the AuryzoN EAR 2.0 device, which standardizes cartilage shaping with specialized blades to reduce operator skill dependence, minimize wire usage, and shorten procedure times. The other group will have surgery using the traditional hand-carved technique, where surgeons manually shape rib cartilage and assemble ear parts with steel wires. The study evaluates differences in appearance, stability, production time, operative time, morbidity, and cartilage resorption over the first year after surgery. Participants will undergo surgery and then be followed for up to five years. Researchers will assess patient and parent satisfaction with the ears shape and look at reductions in surgery and assembly times, wire use, cartilage stability, and resorption rates. Additional tests include tissue analysis of banked cartilage between surgery stages and measuring changes in cartilage size. These evaluations aim to understand the benefits and challenges of the new device compared to traditional methods.

Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction