NCT00981110已完成3 期
Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
European Institute of Oncology3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- The rate of patients with a Surgical site infection
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.
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
- 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
- •Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven)
- •Age 18-75
- •Informed signed consent
- •Performance Status 0-2 (according to ECOG score)
- •Platelets > 50.000/mm3
- •Prothrombin Time (Quick) > 60%
- •White Blood Cells > 2500/mm3
- •Life Expectancy > 3 months
排除标准
- •Intestinal obstruction
- •Severe intestinal bleeding requiring blood transfusion
- •Age under 18 or over 75
- •Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
- •Renal failure (hemodialysis, creatinin > 2.5 mg/dL)
- •Active infections
- •Coagulopathy
- •Inability to give an informed consent
- •Known allergies to dressing components
结局指标
主要结局
The rate of patients with a Surgical site infection
时间窗: 30 days after surgery
次要结局
未报告次要终点
研究者
研究点 (3)
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