Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Between group difference in skin graft take
研究概览
简要总结
The aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18.
详细描述
Split-thickness skin grafting (STSG) is one of the most commonly used techniques in reconstructive plastic surgery and dermatology. Skin grafts are being used to cover skin defects caused by multiple etiologies. Traditionally, patients are immobilized in bed or in wheelchair for up to five days after surgery. Long immobilization decreases patients overall ability to function and increases the length of the stay in hospital. Negative pressure wound therapy (NPWT) have been used successfully in treatment of acute, chronic and diabetic ulcers. It is proposed that NPWT increases capillary blood flow, decreases bacterial contamination, seroma formation and swelling. Using NPWT on split-thickness skin grafts after burns is well documented. It increases skin graft take ratio and speeds up healing. Aim of this study is to compare NPWT to traditional treatment after STSG for any indication in patients aged 18 to 99. This is a two-arm, multicenter, randomized prospective trial with 160 patients.
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
- •Wound requiring skin graft surgery
- •Voluntary
排除标准
- •Not voluntary
- •Size of wound exceeding 15x15cm or 5x20cm
- •Previous skin graft operation to the same wound
- •Inability to co-operate
- •Wound depth over 1.5cm
- •Multiple wounds requiring skin grafting
- •Active infection in wound
- •Active osteomyelitis in region of wound
- •Flap reconstruction of the wound
- •Region of wound not suitable for negative pressure wound therapy (for example toes, foot sole)
结局指标
主要结局
Between group difference in skin graft take
时间窗: 2 weeks after surgery
Split-thickness skin graft take ratio (percentage of surface area)
次要结局
- Strength of pain (wound)(1 year after surgery)
- POSAS score (donor site)(1 year after surgery)
- Change in quality of life(1 year after surgery)
- Between group difference in skin graft take(8 weeks after surgery)
- Strength of pain (donor site)(1 year after surgery)
- Number of visits(Until 8 weeks after surgery)
- POSAS score (wound)(1 year after surgery)
- Strength of itching (wound)(1 year after surgery)
- Strength of itching (donor site)(1 year after surgery)
- Length of stay(Until 8 weeks after surgery)
- Overall satisfaction(1 year after surgery)