A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin
研究概览
简要总结
The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients older than 18 years of age
- •verified deep partial-thickness burns
- •early tangential excision of burn wound (3-5 days after trauma)
排除标准
- •Pregnancy
- •ABSI-Score >13
- •Active tumor or immune-mediated disease
- •Patient refusal
结局指标
主要结局
Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin
时间窗: 1 year
Time to complete re-epithelialisation measured in days after surgery
次要结局
- Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin(1 year)
研究者
Harald Franz Selig
MD, research assistant
Medical University of Vienna