DRKS00003379已完成未知
Prophylactic Mesh Implantation after Abdominal Aortic Aneurysm Repair.A prospective, randomised, controlled study. - AIDA (Abdominal Incision Defect following AAA Surgery)
niversitätklinikum Hamburg-EppendorfUniversitäres Herzzentrum Hamburg0 个研究点目标入组 108 人开始时间: 2011年12月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Male and female patients >18 years of age.
- •2. Patients undergoing an elective surgery for AAA repair.
- •3. Patients who currently have no malignant disease requiring therapy.
- •4. Patients who are able to fulfill all clinical investigation requirements
- •5. Patients who have provided written informed consent.
排除标准
- •1. Patients who require median laparotomy for AAA repair as an emergency procedure.
- •2. Expected length of fascia incision > 30 cm.
- •3. Patients with coagulopathy
- •4. Patients who have had previous median laparotomy and/or laparaotomy crossing the incision necessary for AAA laparotomy.
- •5. Patients with current immunsuppressive therapy (>40 mg corticoid/day or azathioprine).
- •6. Chemotherapy within the last 4 weeks.
- •7. Radiotherapy on the treated region within the last 2 months.
- •8. Pregnant and breast-feeding women.
- •9. Known allergy against ingredients of the investigational products (polypropylene, poly-4-hydroxybutyrate, polydioxanone).
- •10. Patients participating in other investigational drug or medical device studies within the preceding 4 weeks.
- •11. Patients with an ongoing medical condition or social reason that may affect their ability to complete the two years follow-up period.
- •12. Life expectancy less than 24 months.
- •13. Severe psychiatric or neurologic disease.
- •14. Lack of compliance.
- •15. Drug abuse.
- •16. Inability to understand and follow the instructions given by the investigator (e.g. dementia, lack of time, insufficient command of language).
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