NCT02509533终止不适用
Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Percentage of healing between VAC system and compresses for all types of leg ulcers
研究概览
简要总结
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:
- A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
- Consumables necessary for the implementation of the dressing,
- Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.
This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.
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
- 否
入选标准
- •patient hospitalized into the dermatology unit
- •patient with an evolutive leg ulcer since more than 1 month
- •signed informed consent
排除标准
- •known allergy to one of dressings used in this study
- •patient with a non-treated osteomyelitis
- •patient with tumoral tissues into the wound
- •patient with raw organ or raw blood vessels
- •patient with an anticoagulation treatment with a potentially hemorrhagic curative dose
- •patient having hemostasis problems that can lead to hemorrhagic exudates
结局指标
主要结局
Percentage of healing between VAC system and compresses for all types of leg ulcers
时间窗: 1 month after the transplant
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
次要结局
- Percentage of healing between VAC system and compresses for all types of leg ulcers(3 months after the transplant)
- Evolution of the pain by Analogic Visual Scale.(day 1 : the day after the transplant)
- Evolution of the pain by Analogic Visual Scale(Month 1)
- Cost of the treatment.(Month 3)
- Quality of life questionnaire score.(Month 3)
研究者
研究点 (2)
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