Face Reconstruction by Allotransplantation of Composite Tissues
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids.
研究概览
简要总结
To show the feasibility of face transplantation in patients
详细描述
Most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. The study was designed following the advice of the French National Ethics Advisory Committee for life sciences and health (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 through 65 years
- •Signed written informed consent
- •patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid.
- •validation of the feasibility by a committee of expert in plastic surgery and maxillofacial
- •patient with a positive psychologic evaluation
- •patient with an anatomical evaluation and assessment pretransplantation positive normal infectious assessment
- •Good compliance and capacity of adaptation to the assessment difficulties
- •Patient with renal, hepatic, hematologic ,cardiac normal
- •Patient profiting from a Social Security cover
- •Patient informed patient, having signed a free assent lit with inclusion in the study
排除标准
- •patient minor under supervision or deprived of freedom by court order or administrative.
- •person remaining in a medical or social establishment
- •pregnant. or breast-feeding women
- •patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational
- •patient presenting a hepatic pathology
- •Any cancer that has been in complete remission for > 5 years malignancies tumoral lesion of the face with 2 years deadline of remission respected renal insufficiency chronic clearance of creatin < 60l ml/mn
- •chronic respiratory insufficiency
- •patient presenting an active infection which can be worsened by the immunosuppression
- •patient presenting an active infection which can be worsened by the corticoid
- •patient with affection being able to compromise post-operative survival
- •patient with digestive ulcer
- •No known HIV infection
- •serology hepatitis B with circulating DNA highlighted quantitatively
- •personality emotional unstable
- •schizophrenic or not schizophrenic psychosis
结局指标
主要结局
Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids.
时间窗: during the study
次要结局
- To evaluate the potential benefit of such a transplantation in term of quality of life(during the study)
- To measure the impact of this improvement(during the study)
- To measure the impact of a immunosuppressive treatment for a pathology which is not vital(during the study)
- To evaluate Acute Graft rejection using skin and mucosa biopsies: function of the lips and or eyelids mobility and function of the orbicularis muscles Quality of life the psychiatric and psychological evaluations(at in the following days weeks and month after surgery)