NCT01019447已完成4 期
"The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection" Prospective, Randomized, Controlled, Double Blind, Multi-centre Study.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 701
- 试验地点
- 2
- 主要终点
- Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria
研究概览
简要总结
To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of different age
- •Risk factors and procedures candidate for surgical intervention during the period of the study
排除标准
- •Patients with an established pre-operative infection at the operative site
研究组 & 干预措施
Study group
Active Comparator
The study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used.
干预措施: Vicryl Plus (Other)
Control group
Active Comparator
The control group in which polyglactin 910 antimicrobial sutures will be used.
干预措施: Vicryl (Other)
结局指标
主要结局
Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria
时间窗: 30 days (or 1 year in case of prosthesis)
次要结局
- Post-operative hospital stay in days(30 days)
研究者
研究点 (2)
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