NCT00646334已完成不适用
A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 80
- 试验地点
- 12
- 主要终点
- Physical function score of the SF-36 questionnaire
研究概览
简要总结
Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the patient's daily activity, the rating of patients pain and the wound assessment determined on several occasions during the six months observation time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients >=18 years
- •Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation
- •Patients wiht vertical aponeurotic incisions only
- •Incisional hernia with hernia size >= 3 cm
- •Patient is capable to understand and to follow the instructions
- •written informed consent
- •no mesh implantation at the same site during a previous operation
- •immune competence of patient
排除标准
- •Simultanous participation in an investigational drug or medical device study
- •Patients < 18 years old
- •Incisional Hernia withe a hernia size < 3 cm
- •Repair of an acute incarcerated hernia
- •Previous mesh repair at the same site
- •Patient with other than vertical aponeurotic incisions
- •Enterotomy to be performed during hernia repair at Surgery
- •Patient is on anti-coagulations-therapy
- •Patient is known or assessed to be non-compliant
- •Additional surgical treatment at the same time (e.g. cholecystectomy)
- •Immune incompetence of patient (e.g. chemotherapy)
研究组 & 干预措施
A
Experimental
Optilene® Mesh Elastic
干预措施: Mesh Implantation (Device)
B
Active Comparator
Ultrapro® Mesh
干预措施: Mesh Implantation (Device)
结局指标
主要结局
Physical function score of the SF-36 questionnaire
时间窗: 21 days after insertion
次要结局
- wound assessment(6 months postoperatively)
- patient's daily activity(6 months postoperatively)
- physical function score from the SF-36 questionnaire(6 months postoperatively)
- patient's pain(6 months postoperatively)
研究者
研究点 (12)
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