The Use of "Negative Pressure Drainage System" for Caring Split-thickness Skin Graft Recipient Sites
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Healing of the wound at the 7th day after operation
研究概览
简要总结
To compare the efficacy and safety of negative pressure drainage system with controls (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin graft.
详细描述
Randomized, comparator-controlled trial in patients underwent split-thickness skin graft conducted in Taipei Veterans General Hospital between Aug. 2012 and Dec. 2013. (No.) patients age 21 to 60 years were randomly assigned in the intervention group (n= ) of negative pressure drainage system or to a control group (n= ) of traditional method. Patients who had immunologic disease, end-stage renal disease, coagulopathy, or history of radiation were excluded. The conditions of graft take and pain and discomfort were compared every day during the first 7 days after operation and 2 weeks and 3 months follow up.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 to 60 years
- •The wounds located on limbs or trunk
- •The area of wounds is ranged 50 to 250cm2.
排除标准
- •immunodeficiency disease
- •end stage renal disease
- •coagulopathy
- •history of radiation to the recipient site
- •allergy to the dressing
- •major medical problems
研究组 & 干预措施
Negative pressure drainage system
Negative pressure drainage system
干预措施: Negative pressure drainage system (Device)
Indirect wet dressing group
Indirect wet dressing
干预措施: Indirect wet dressing (Device)
结局指标
主要结局
Healing of the wound at the 7th day after operation
时间窗: 1 week
次要结局
- Pain, Comfort, and satisfication of the device(one week)
- Long term wound condition(three months)