NCT01514383已完成4 期
Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
Medline Industries3 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Wound Length Closure
研究概览
简要总结
The purpose of this study is to evaluate how surgical adhesive is used.
详细描述
In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for use of a topical surgical skin adhesive
排除标准
- •Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
- •Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
- •Subjects who present with a contraindications for product usage as per labeling
- •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 bodily fluids or with dense natural hair
- •Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
研究组 & 干预措施
Surgical Adhesive
Experimental
The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.
干预措施: Cyanoacrylate (Octylseal ) (Device)
结局指标
主要结局
Wound Length Closure
时间窗: During Surgery
Primary incision wound length treatment in adult and pediatric general surgery
次要结局
- Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale(At Surgery)
研究者
研究点 (3)
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