Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Healing of skin graft between the two Methods
研究概览
简要总结
The single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite.
Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.
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
- 是
入选标准
- •>18 years
- •Signed informed consent
- •Surgical wound (excision of skin cancer)
排除标准
- •Malignant melanoma
- •Signs of infection
- •Exposed tendon/bone in wound
- •Burn/chronic wound
研究组 & 干预措施
Compression bandaging (Coban 2 lite)
In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers.
干预措施: Coban 2 lite (Other)
NPWT (PICO device)
In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
干预措施: PICO (Device)
结局指标
主要结局
Healing of skin graft between the two Methods
时间窗: 30 days postoperatively
Numbers of patients with 100 % healing of the split thickness skin graft
次要结局
- Evaluation of pain with VAS (Visual analogic scale)(0, 5-7, 10-14 and 30 days postoperatively)
- Percentage of healing between the two Methods(30 days postoperatively)
- Level of function(30 days postoperatively)
研究者
Martina Eva Kristiansen
MD
Oslo University Hospital