NCT00675974撤回2 期
Prospective Randomized Study of the Effectiveness of Prospective Randomized Study on the Effectiveness of Pressure Garment Therapy for the Prevention of Hypertrophic Scarring in Burned Children
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Differences in scarring between pressure garment therapy and no pressure garment therapy
研究概览
简要总结
- Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
- How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
- Will Pressure Garment Therapy diminish discomfort due to pruritus.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
- •at least 1 year of age and no more than 17 years of age
- •Wound closure
- •No evidence of deep venous thrombosis or other vascular compromise.
- •No concomitant conflicting study protocols.
排除标准
- •Burn injuries not bilateral to upper and/or lower extremities.
- •Evidence of vascular compromise.
- •Conflicting protocols.
结局指标
主要结局
Differences in scarring between pressure garment therapy and no pressure garment therapy
时间窗: Time of burn to 2 years post burn
次要结局
- Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.(Time of burn to 2 years post burn)
- Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy(Time of burn to 2 years post burn)
研究者
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