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临床试验/NCT01622127
NCT01622127已完成不适用

Efficacy of Self-fixating Mesh in Ventral and Incisional Hernia Repair

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Incidence of peri-operative and post-operative complications using Parietex ProGrip™.

研究概览

简要总结

A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair.

Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients at participating hospital undergoing incisional hernia repair by using retromuscular placement by open approach.
  • Defect size: 5cm ≤ width*, 10 cm ≤ length ≤ 20 cm

排除标准

  • 未提供

结局指标

主要结局

Incidence of peri-operative and post-operative complications using Parietex ProGrip™.

时间窗: 24 months after surgery

Clinical observation: recurrence, wound complications pain, pain/ chronic pain and other postoperative complications

次要结局

  • Description and assessment of the use of Parietex™ ProGrip™ larger sizes meshes at time of surgery(End of surgical procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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