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临床试验/NCT02223689
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

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

发起方
Medline Industries
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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