NCT00203541终止不适用
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
研究概览
简要总结
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
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
- •Sign an informed consent form that has been approved by the Institutional Review Board.
- •Adults at least 18 years of age.
- •Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
- •Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.
排除标准
- •Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
- •Be in need of a left ventricular assist device.
- •Have an active pre-operative infectious process.
- •Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).
结局指标
主要结局
Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
次要结局
- Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group
研究者
研究点 (2)
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