A 3D Regenerative Scaffold for Inguinal Hernia Repair. MR Imaging and Histological Cross Evidence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- tissue incorporation into ProFlor in the mid term postop.
研究概览
简要总结
Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor
详细描述
The biological response of the 3D inguinal hernia scaffold ProFlor has been evaluated through MRI signal intensity (SI) at three defined post-implantation stages: short, mid and long term. The SI of ProFlor has been compared to the SI of the neighbouring muscles and fat. As additional proof, histology of tissue specimens excised at the identical post-implantation stages from porcine models in the fame of a previous experimental attempt were also evaluated. The results of this experimental trial have ben already published in 2011 - ref: A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artificial Organs 2011;35(8):E181-E190
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who underwent inguinal hernia repair with the 3D inguinal hernia scaffold ProFlor
排除标准
- •all individuals who underwent inguinal hernia repair withouth the 3D inguinal hernia scaffold ProFlor
结局指标
主要结局
tissue incorporation into ProFlor in the mid term postop.
时间窗: 4-7 months post implantation
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
tissue incorporation into ProFlor in the long term postop.
时间窗: 8 months post implantation
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
tissue incorporation into ProFlor in the short term postop.
时间窗: 1- 3 weeks post implantation
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
次要结局
未报告次要终点
研究者
Giuseppe Amato
Consultant Professor
University of Cagliari