NCT01457859Unknown4 期
Effectiveness of Triclosan Coated VICRYL\MONOCRYL Sutures in Preventing Leg Wound Infection Compared to POLYSORB\ BIOSYN Sutures in Patients After Coronary Bypass Surgery- a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- leg wound infection
研究概览
简要总结
The purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older with written informed consent
- •Male and female subjects
- •Subjects scheduled for an elective and urgent CABG surgery that includes saphenous vein harvesting.
排除标准
- •Known allergy or intolerance to triclosan
- •Different surgical prophylactic antibiotic regimen than common in the department.
- •Continuous preoperative and predicted postoperative antibiotic treatment.
研究组 & 干预措施
Conventional sutures
Active Comparator
干预措施: Conventional non-coated surgical sutures (Other)
Antiseptic sutures
Experimental
干预措施: Triclosan (Drug)
结局指标
主要结局
leg wound infection
时间窗: Up to 45 days postsurgery
Proportion of subjects with leg wound infection in research versus control group within 45 days of surgery according to CDC SSI criteria
次要结局
- Antibiotics administration(Up to 45 days postsurgery)
- Hospital Length of stay(Average of 7 days postsurgery)
- Incidence of hospital re-admission due to leg wound infection(Within 45 days postsurgery)
研究者
Dr. Shani Liran
Cardiac surgery resident
Rambam Health Care Campus
研究点 (1)
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