NCT00674999撤回2 期
Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Length of time to 95% healing of treated burn wounds
研究概览
简要总结
To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.
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
- •Partial thickness burn injury.
- •>2% burn injury.
- •Ages 0-100 years.
排除标准
- •Patients not expected to survive
研究组 & 干预措施
1
Experimental
Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)
干预措施: Amnion (Biological)
2
Experimental
Amnion with processing procedures involving the use of Dispase II
干预措施: Amnion (Biological)
3
Active Comparator
Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin
干预措施: Polysporin/Bacitracin/Mycostatin (Drug)
结局指标
主要结局
Length of time to 95% healing of treated burn wounds
时间窗: Assessment daily until 95 % healed
次要结局
- Length of hospital stay(Measured at hospital discharge)
- Incidence of infection(Measure daily until complete wound healing)
- Amount of daily pain until wound is healed with different treatments.(Daily until wound is completely healed.)
- Amount of scaring with different treatments(From injury to 2 years post burn)
研究者
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