Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percentage of Grafted Area That is Viable at Day 14
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female, aged 18 years and over requiring hospitalization for burn injury
- •Burn injury requiring wound excision and auto-grafting
- •Less than or equal to 20% Total Body Surface Area burns
排除标准
- •Pregnant or lactating females
- •Individuals with chlorine sensitivity
- •Electrical, chemical and cold injury
- •Burns to the face, hands, feet and or perineum area
- •Steroid therapy
研究组 & 干预措施
Vashe
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
干预措施: Vashe (Device)
5% Mafenide Acetate
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
干预措施: Mafenide acetate (Drug)
结局指标
主要结局
Percentage of Grafted Area That is Viable at Day 14
时间窗: 14 days
Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color
次要结局
- Length of Stay(0 days, 3 days, 5 days and 14 days post-operation)
- Hospital Cost Per Patient(Volume used from admission to discharge)