Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Proportion of subjects with leg wound infection.
研究概览
简要总结
The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.
详细描述
The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.
排除标准
- •Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.
研究组 & 干预措施
Control group
Ordinary sutures (Vicryl / Monocryl) is used for wound closure
Group A
Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure
干预措施: Triclosan coated sutures (Device)
结局指标
主要结局
Proportion of subjects with leg wound infection.
时间窗: Within 60 days after heartsurgery
Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.
次要结局
- Culture-proven and antibiotic-treated wound infection after heart surgery(Within 60 days after heart surgery)
研究者
Anders Jeppssons
Professor, Cardiothoracic surgery
Sahlgrenska University Hospital