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临床试验/NCT01320514
NCT01320514Unknown不适用

A Randomized, Controlled Study to Evaluate Safety and Efficacy of Fibrin Sealant VH S/D 4 S-APR (Artiss) for Tissue Adherence and Hemostasis and To Improve Wound Healing in Subjects Undergoing Endoscopic Browlift

Nguyen, Davis B., M.D.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Comparison of ecchymosis and edema

研究概览

简要总结

The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects planned for endoscopic browlift, subjects who read, understand and sign the written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements

排除标准

  • Subjects who had previous browlift, subjects indicated for concurrent facial surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.

研究组 & 干预措施

Fibrin Sealant (Artiss)

干预措施: Fibrin Sealant (Artiss) (Drug)

结局指标

主要结局

Comparison of ecchymosis and edema

时间窗: 30 days

次要结局

  • Resolution of ecchymosis and edema, incidence of hematoma/seroma(30 days)

研究者

发起方
Nguyen, Davis B., M.D.
申办方类型
Indiv

研究点 (1)

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