Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
研究概览
简要总结
The investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within ProFlor, a 3D dynamic responsive implant for inguinal hernia repair
详细描述
Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 dynamic responsive device named ProFlor
- •Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor
- •Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor
排除标准
- •immunosoppressive therapy, > ASA 4 classification
结局指标
主要结局
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
时间窗: 6-8 months post implantation
Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation
次要结局
未报告次要终点
研究者
Giuseppe Amato
Consultant Professor
University of Cagliari
