Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluation of cartilage stability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of cartilage stability
时间窗: From the beginning of the study to the end at 5 years
Assess cartilage framework stability over 12 months post-surgically using photography, measurements, 3D imaging, and histopathological analysis.
Evaluation of resorption rates
时间窗: From the beginning of the study to the end at 5 years
Assess resorption rates over 12 months post-surgically using photography, measurements, 3D imaging and histopathological analysis.
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.
时间窗: From the beginning of the study to the end at 5 years
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.
时间窗: From the beginning of the study to the end at 5 years
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.
时间窗: From the beginning of the study to the end at 5 years
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
时间窗: From the beginning of the study to the end at 5 years
Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.
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.
时间窗: From the beginning of the study to the end at 5 years
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.
时间窗: From the beginning of the study to the end at 5 years
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.
时间窗: From the beginning of the study to the end at 5 years
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
时间窗: From the beginning of the study to the end at 5 years
Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.
Evaluation of cartilage stability
时间窗: From the beginning of the study to the end at 5 years
Assess cartilage framework stability over 12 months post-surgically using photography, measurements, 3D imaging, and histopathological analysis.
Evaluation of resorption rates
时间窗: From the beginning of the study to the end at 5 years
Assess resorption rates over 12 months post-surgically using photography, measurements, 3D imaging and histopathological analysis.
次要结局
- Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery.(From the beginning of the study to the end at 5 years)
- Conduct histopathological analysis assessing outcomes of banked allogeneic cartilage between stage 1 and stage 2 surgeries(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.(From the beginning of the study to the end at 5 years)
研究者
Angelo Leto barone
Craniofacial and Pediatric Plastic Surgeon
Nemours Children's Clinic