Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis.
研究概览
简要总结
The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds.
Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.
详细描述
This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 30% total body surface area burn
- •burn wounds do not involve the donor site harvesting areas
- •requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces.
- •The scheduled excision and grafting procedure is the first such operation for the subject
- •subject agrees to participate in follow-up evaluations
排除标准
- •Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability
- •Major acute or chronic medical illness that could affect wound healing
- •Cellulitis or other infection of the potential donor sites
- •Donor site has been previously harvested for grafting
- •Subjects who are pregnant
- •Religious objections or allergy to porcine products
结局指标
主要结局
The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis.
时间窗: 14 days
次要结局
未报告次要终点