NCT01790763撤回2 期
Prospective,Randomized, Parallel Study to Compare the Efficacy of Mepilex and Keramatrix in Promoting Healing of Second Degree Burn Wounds
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Wound Healing
研究概览
简要总结
The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.
详细描述
Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.
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 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician
排除标准
- •Patient older than 18
- •Causes other than flame or scald injuries (ie.chemical or frostbite)
- •Wounds noted to be contaminated or infected
- •Patients who have received previous treatment efforts (topical dressings or previous wound debridement)
- •Pregnancy lactation
- •Co-morbidity which may compromise healing: known history of AIDS, ARC, HIV, cancer, autoimmune diseases,cirrhosis, tuberculosis, chronic glucocorticoid therapy, diabetes mellitus, renal insufficiency, hepatic disease, congestive heart failure prior to burn injury, associated severe head injury requiring specific treatment
- •known allergy to sheep's wool
研究组 & 干预措施
Keramatrix
Active Comparator
Keramatrix
干预措施: Keramatrix (Device)
Mepilex
Active Comparator
Mepilex
干预措施: Mepilex (Device)
结局指标
主要结局
Wound Healing
时间窗: Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals
Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds.
次要结局
- Scarring(52 weeks up to 78 weeks)
- Infection rates(Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals)
- Pain(duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals, up to 3 times a week during dressing changes)
研究者
研究点 (1)
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