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临床试验/NCT00837954
NCT00837954已完成4 期

Randomized, Controlled, Prospective Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

Aesculap AG2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Aesculap AG
入组人数
32
试验地点
2
主要终点
Time to hemostasis

研究概览

简要总结

The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®

详细描述

Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. Polytetrafluorethylene (PTFE) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). However, the insufficient elasticity of PTFE and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2).

This study is designed to demonstrate the superiority of Lyostypt® to oxidized cellulose (Surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. Lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Therefore collagen is very effective in hemostasis. Collagen is cell-friendly whereas other hemostats significantly disturb cell growth. Advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). Furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. Authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).

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
None

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

  • Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
  • suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
  • Written informed consent

排除标准

  • Emergency surgery
  • Patients with coagulopathy or uremia
  • Reoperation within one month at the same location
  • Pregnant and Breastfeeding Women
  • Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
  • Severe comorbidity (ASA ≥ 4)
  • Life expectancy less than 12 months
  • Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
  • Chemotherapy within last 4 weeks
  • Radiotherapy on the treated region within the last 2 months
  • Severe psychiatric or neurologic diseases
  • Lack of compliance

结局指标

主要结局

Time to hemostasis

时间窗: Minutes

次要结局

  • Number of Complications(30 days after surgery)
  • Postoperative Mortality(30 days after surgery)
  • Efficacy Rating of Study Device evaluated by Surgeon(intraoperatively)

研究者

发起方
Aesculap AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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