Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Official title

Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study

Overview

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.

Detailed 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 wire extrusion, cartilage resorption, and overall high cost. The previously published prototype device utilized specialized blades to standardize this process. Given the complexity of auricular reconstruction and the suboptimal outcomes by most plastic surgeons globally, there is a pressing need for a standardized, enhanced and accessible method for an accurate ear framework.

If successful, this project has the potential to improve plastic surgeons' technical proficiency in producing anatomically accurate auricular frameworks. Achieving these aims could substantially advance reconstructive clinical techniques in clinical practice and broaden access to satisfactory ear reconstruction beyond the limited number of highly specialized centers. Furthermore, the novel blade design has the potential to reduce the need for wire suturing, while also reducing overall framework production time, anesthesia duration, and costs.

Comparing hand-carved and blade-cut techniques for cadaveric cartilage, the study will enhance understanding of potential differences in resorption rate between these methods. This study aims to: 1. Promote framework production through precise bladecutting, facilitating the construction of cartilaginous ear frameworks while improving outcomes and reducing operative time and costs; 2. Standardize framework production independently of operator skill. 3. Reduce the number of wires required for construct fixation, further contributing to decreased operative time and cost; 4. Minimize the risk of wire extrusion by limiting wires usage during framework production through the novel blade design. 5. Compare differences in framework appearance, stability, time to production, operative time, intraoperative morbidity, and construct resorption within the first year postoperatively when using cadaveric cartilage.

Interventions

• Procedure Use 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.
• Procedure Hand carving
  Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.

Primary outcome measures

• 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. [Time frame: From the beginning of the study to the end at 5 years]
• Evaluating reduction in operative time between the two techniques. [Time frame: From the beginning of the study to the end at 5 years]
• Evaluating reduction in assembly time between the two techniques. [Time frame: From the beginning of the study to the end at 5 years]
• Evaluating reduction in wire usage between the two techniques [Time frame: From the beginning of the study to the end at 5 years]
• Evaluation of cartilage stability [Time frame: From the beginning of the study to the end at 5 years]
• Evaluation of resorption rates [Time frame: From the beginning of the study to the end at 5 years]

Secondary outcome measures (2)

• Conduct histopathological analysis assessing outcomes of banked allogeneic cartilage between stage 1 and stage 2 surgeries [Time frame: From the beginning of the study to the end at 5 years]
• Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery. [Time frame: From the beginning of the study to the end at 5 years]

Eligibility criteria

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 ≥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
• Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent
• Lack of fluency in English or Spanish to complete patient/parent surveys

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Nemours Children's Hospital, Florida — Orlando

Publications

• Nagata S. A new method of total reconstruction of the auricle for microtia. Plast Reconstr Surg. 1993 Aug;92(2):187-201. doi: 10.1097/00006534-199308000-00001. PMID 8337267
• Tanzer RC. Microtia--a long-term follow-up of 44 reconstructed auricles. Plast Reconstr Surg. 1978 Feb;61(2):161-6. doi: 10.1097/00006534-197802000-00001. PMID 622405
• Su-Genyk P, Quatela O, Quatela V. Our Evolution of Approaches to Microtia Reconstruction. Facial Plast Surg Clin North Am. 2024 Feb;32(1):105-125. doi: 10.1016/j.fsc.2023.09.002. PMID 37981407

Identifiers

NCT: NCT07154667 · STUDY00000371

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗