NCT02223689已完成4 期
Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
Medline Industries2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Wound Closure at Discharge
研究概览
简要总结
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
详细描述
Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.
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
- 5 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 5 years of age
- •Requires the use of a surgical skin adhesive
- •Informed consent signed
排除标准
- •Sensitivity to topical adhesive products or formaldehyde
- •Hx keloid formation, hypotension, diabetes, blood clotting disorders
- •Wound infections
- •mucosal surfaces or skin exposed to body fluids
结局指标
主要结局
Wound Closure at Discharge
时间窗: 14 days
Wounds remained closed following application of Skin Affix
次要结局
- Change in Pain Following Application(15 minutes Post Application)
研究者
研究点 (2)
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