Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 主要终点
- Surgical site infection
研究概览
简要总结
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.
详细描述
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men and women, >18 years of age;
- •Scheduled for elective colon procedure;
- •Ability to complete patient survey questionnaires;
- •Provision of informed consent
排除标准
- •Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
- •Procedures for hemorrhoids;
- •Inability to perform follow up assessments
研究组 & 干预措施
Control
Hospital standard of care for pain management (Patient controlled analgesia or epidural)
干预措施: Patient controlled analgesia (Drug)
Active
Surgical site continuous local anesthetic infusion with ONQ silver Soaker System
干预措施: ON-Q Silver soaker System (Device)
结局指标
主要结局
Surgical site infection
时间窗: 30 days postoperative
次要结局
- Hospital length of stay(Average 1 week)