A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Complete Wound Healing
研究概览
简要总结
This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skin graft donor sites total surface < 15% BSA
- •Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area
排除标准
- •Patients treated with immunosuppressors
- •Patients treated with corticoids
- •Patients suffering from terminal renal insufficiency
- •Patients suffering from severe peripheral arteriopathy
研究组 & 干预措施
Control
Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
干预措施: Standard dressings (Other)
PRP
PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
干预措施: Autologous Platelet Rich Plasma (Biological)
PRP
PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
干预措施: Standard dressings (Other)
PRP+K
Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
干预措施: Autologous Platelet Rich Plasma (Biological)
PRP+K
Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
干预措施: Keratinocyte suspension (Biological)
PRP+K
Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
干预措施: Standard dressings (Other)
结局指标
主要结局
Complete Wound Healing
时间窗: Post operative day 5 and every other day thereafter
Time required for complete epithelialization in days
次要结局
- Pain(Post operative day 5)