Auricular Reconstruction in Microtia by Medpor Implant Following Tissue Expansion
试验速览
- 阶段
- 不适用
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Efficacy of Medpor implant after tissue expansion in treatment of Microtia through comparison with the normal ear regarding skin color, shape, size and patient or relatives satisfaction which will be assessed by likert scale
研究概览
简要总结
The study involves patients with microtia of certain criteria will undergo tissue expansion by silicone bags in the postauricular region then Medpor implants will be applied undercover of the expanded skin for reconstruction of the auricule instead of the costal cartilage graft
详细描述
Background :
Autologous multistage rib cartilage technique for auricular reconstruction was firstly introduced by Tanzer in 1959(1) however, such technique had many drawbacks like being a lengthy process consisting of multiple procedures, donor-site morbidity and pain and the possibility of cartilage resorption leading to poor ear projection and loss of auricular definition (2). Tjellström (3) and Korus et al (4) described the osseointegrated implant for auricular reconstruction in traumatic congenital and oncological conditions. It also had disadvantages as the need for long-term commitment of both patient and prosthetic team, high costs of maintenance visits, regular change of the prosthesis every 2 to 5 years and the prosthesis is considered as a foreign body (5). Medpor is a synthetic biocompatible porous polyethylene implant (5) that was used as an alternative to conventional autologous rib cartilage graft for ear reconstruction for the first time by Reinisch (6). This technique was faced by many arguments like implant fracture, necrosis and failure of healing of the overlying soft tissue due to foreign body reactions to the Medpor implant (5). Many studies were conducted to compare those various techniques specially the Medpor implant and rib cartilage graft but, the superiority of neither of them proved clearly (7).
Aim of the Research :
Evaluation of the outcome of auricular reconstruction in microtia by Medpor implant following tissue expansion.
Research Methods and techniques:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral microtia
- •Age not less than six years
- •Non-syndromatic microtia
排除标准
- •• Bilateral microtia
- •Age less than six years
- •Syndromatic microtia
- •Previous ear surgery through postauricular incision
结局指标
主要结局
Efficacy of Medpor implant after tissue expansion in treatment of Microtia through comparison with the normal ear regarding skin color, shape, size and patient or relatives satisfaction which will be assessed by likert scale
时间窗: Three years
• The research will describe and assess the new technique for reconstruction of microtia by Medpor implant which is a new service not performed in Assiut university that skips the complications of the traditional rib cartilage multistage technique , Also it will assess the degree of patient and family satisfaction. Research on this new service has not been performed in Assiut university.
次要结局
未报告次要终点
研究者
Mina Youssef Asham Gendy
Assistant Lecturer of ENT
Assiut University