A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- 80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
研究概览
简要总结
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns
详细描述
Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.
Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.
Give an information about efficiency improvement of RECELL® with additional costs
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thermal burns requiring surgical debridement
- •Area involved < 1260cm²
排除标准
- •local or systemic infection
- •conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
- •hypersensitivity to trypsin
研究组 & 干预措施
1
Treatment of acute burn in adults and children by epidermal cell spray
干预措施: autologous epidermal cells harvesting kits (Device)
2
Treatment of acute burn in adults and children by classic skin grafts
干预措施: classic skin grafts (Procedure)
结局指标
主要结局
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
时间窗: at 1, 2 and 6 weeks
次要结局
- Medical costs at complete epithelialisation(At 6, 12 and 18 months)
- Post-operative pain(At 6 weeks)
- Medical assessment of scar quality(at 6 weeks and 6, 12, 18 months)
- Patient self assessment of scar(At 6, 12 and 18 months)