Neptune Pad ® Compared to Conventional Manual Compression for Access Site Management After Peripheral Percutaneous Transluminal Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
研究概览
简要总结
BACKGROUND. Arterial access site complications remain the most frequent adverse events after percutaneous transluminal procedures. We investigated the safety and efficacy of the pro-coagulant wound dressing Neptune Pad ® compared to conventional manual compression for access site management after peripheral percutaneous interventions.
METHODS. We enrolled 201 consecutive patients and randomly assigned patients for Neptune Pad ® (n=100) vs. conventional manual compression (n=101). Patients were followed clinically until hospital discharge and by duplex ultrasound at 24 hours postprocedure for occurrence of access site complications. Time-to-hemostasis and time-to-ambulation were recorded, patients´ and physicians´ discomfort were measured using a visual analogue scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inguinal punctures (common femoral, superficial femoral and deep femoral artery, antegrade and retrograde access) were included.
- •No specific limitations of anti-platelet or anti-coagulant medication were specified.
排除标准
- •Patients with extreme obesity (BMI above 35 kg/m2) were not included according to the manufactures' recommendations.
- •Furthermore, patients with known hypersensitivity to components of the device were not eligible