Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor
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 Nervous 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 nervous elements within 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 neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, 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
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
- •Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
- •Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor
排除标准
- •Patients who underwent inguinal hernia repair with conventional flat meshes
结局指标
主要结局
Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor
时间窗: 3 weeks until 8 months post-implantation
Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation
次要结局
未报告次要终点
研究者
Giuseppe Amato
Consultant Professor
University of Cagliari
