NCT02353507撤回4 期
A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects
Medline Industries0 个研究点开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Wound Infection Rates
研究概览
简要总结
The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient status at the site
- •Written consent obtained from the subject
- •Burn injury must have been incurred within 36 hours prior to enrollment.
- •Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
- •Burn injury must exceed 3% total body surface area.
排除标准
- •Subject is pregnant.
- •Bone fractures.
- •Inhalation-related trauma.
- •Sensitive and/or allergic to materials containing silver.
- •Burn injury exceeds 40% total body surface area.
- •Burn injury diagnosis indicates deep partial or full thickness wounds.
- •Burn a result of electrical/chemical injury or frostbite.
- •An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.
结局指标
主要结局
Wound Infection Rates
时间窗: Up to 21 days of use
Days required for wound healing
时间窗: Up to 21 days of use
次要结局
- Pain Levels during Dressing Removal(Up to 21 days)
研究者
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