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临床试验/NCT03316924
NCT03316924已完成不适用

Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
cell colonization

研究概览

简要总结

In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development.

After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
0 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Minor aged 0 (day of birth) to 14 years
  • Patient for whom an indication of posthectomy and / or cure of inguinal hernia and / or testicular ectopy is retained
  • Patient whose legal representatives have agreed to the use of operational waste from mesenchymal tissues (foreskin, cremaster and peritoneum) destined for incineration.
  • Patient affiliated to a social security scheme

排除标准

  • parents don't agree to the use of its operating waste for research purposes

结局指标

主要结局

cell colonization

时间窗: samples are processed immediately after sampling

Study cell colonization

quality of the extracellular matrix

时间窗: samples are processed immediately after sampling

Quality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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