Non-cultured Autologous Keratinocyte Suspension for Treatment of Deep Dermal Burn and Post-Burn Raw Area Versus Traditional Split Skin Graft
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- mean Hospital stay
研究概览
简要总结
A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft
详细描述
Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.
Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.
Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.
For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.
However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh inter-sites.
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
- •Deep dermal burns more than 10% total body surface area which require surgical debridement and epidermal replacement.
- •Post-burn raw area more than 10% total body surface area
排除标准
- •Presence of pre-existing local and systemic bacterial infections.
- •Pre-existing medical conditions that would interfere with wound healing (uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).
结局指标
主要结局
mean Hospital stay
时间窗: 1 month
Number of days patient stays admitted
次要结局
- mean healing time(1 month)
研究者
Sara Diefy Salem
Principal investigator
Assiut University
