NCT01237392已完成不适用
Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial
Calvary Hospital, Bronx, NY2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Time to complete wound closure
研究概览
简要总结
A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic wound needing debridement >3 cm2
- •Ulcer history >4mo
- •Adequate arterial blood flow (ABI>0.7)
- •Venous, Inflammatory, Pressure, Diabetic
排除标准
- •Bleeding disorder
- •Uncontrolled diabetes
- •Taking systemic corticosteroids
- •Chemotherapy
- •Participating in another study
- •Treatment with Apligraft, Dermagraft, or Regranex within 90 days
结局指标
主要结局
Time to complete wound closure
时间窗: 12 and 24 weeks
次要结局
- Relative rate of wound healing(8, 12 and 24 weeks)
研究者
Oscar M. Alvarez, PhD
Director, Center for Curative and Palliative Wound Care
Calvary Hospital, Bronx, NY
研究点 (2)
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