The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Burn Scar Comparison
研究概览
简要总结
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:
- will reduce scar formation of skin grafts
- will reduce burn wound contractures
- will improve functional outcome of joints requiring grafts
Compare scarring outcome of Dermal products
详细描述
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn injury requiring grafting
- •0 years-90 years
排除标准
- •Partial thickness burns only
研究组 & 干预措施
Alloderm, Integra, Homograft, Autograft
Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
干预措施: Integra (Procedure)
Alloderm, Integra, Homograft, Autograft
Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
干预措施: AlloDerm (Procedure)
Alloderm, Integra, Homograft, Autograft
Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
干预措施: Homograft (Procedure)
Alloderm, Integra, Homograft, Autograft
Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
干预措施: Autograft (Procedure)
结局指标
主要结局
Burn Scar Comparison
时间窗: 2 years post burn injury
Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.
次要结局
未报告次要终点