NCT01514396已完成不适用
Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series
Medline Industries2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants With Wound Closure
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).
详细描述
Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 5 and 18 years of age, inclusive
- •Candidate for use of a topical surgical skin adhesive
- •Informed consent by a parental guardian
排除标准
- •A wound with evidence of active infection or gangrene or wounds of decubitus etiology
- •Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to body fluids or dense natural hair
- •Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
研究组 & 干预措施
Surgical Glue
Experimental
Surgiseal
干预措施: Surgiseal (Device)
结局指标
主要结局
Number of Participants With Wound Closure
时间窗: baseline to 14 days
wound closure measured baseline to 14 days
次要结局
- Adverse Events Related to Wound Closure(14 days)
研究者
研究点 (2)
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