Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline ASEPSIS score of wound healing at 6 weeks.
研究概览
简要总结
This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein.
- •Must be 18 years or older.
- •Must live with one hour driving distance from Calgary.
- •Must provide written consent.
排除标准
- •Previous CABG surgery or previous lower leg surgical intervention.
- •In emergent need for surgery.
- •Have severe peripheral vascular disease.
- •Do not speak and read the English language.
- •Have dialysis-dependent renal failure.
- •Require chronic steroids.
- •Unable to return to clinic for follow-up due to functional or cognitive impairment.
结局指标
主要结局
Change from baseline ASEPSIS score of wound healing at 6 weeks.
时间窗: Baseline and 6 weeks
The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.
次要结局
- Total score of pain level.(Baseline and 6 weeks)
研究者
Dr. Paul Fedak
Associate Professor
University of Calgary