NCT04256824招募中4 期
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study
ClinAmygate1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2020年2月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Incidence of surgical site infection
研究概览
简要总结
Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery
详细描述
Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-75
- •clean-contaminated wound surgery
排除标准
- •Patient has immunodeficiency disorder.
- •Patient receiving anti-cancer / immunosuppressive therapy.
- •Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
研究组 & 干预措施
Coated Polyglactin 910 with Triclosan
Experimental
Coated vicryl plus
干预措施: coated vicryl plus (Drug)
Coated Polyglactin 910 without Triclosan
Active Comparator
Coated vicryl
干预措施: Vicryl (Drug)
结局指标
主要结局
Incidence of surgical site infection
时间窗: 30 days
Incidence of surgical site infection within 30 days
次要结局
- Hospital stay(30 days)
研究者
研究点 (1)
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