A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 627
- 试验地点
- 34
- 主要终点
- Percent of Subjects With Surgical Site Infections (SSI)
研究概览
简要总结
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
详细描述
The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Is male or female, 18 years of age or older
- •Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)
- •Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or
- •Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure
排除标准
- •Known allergy to Chlorhexidine Gluconate (CHG)
- •Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients
- •American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.)
- •Female volunteers who are pregnant and/or breast feeding
- •Damage control laparotomy
- •Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta)
- •Currently enrolled in an ongoing, interventional, randomized clinical trial
结局指标
主要结局
Percent of Subjects With Surgical Site Infections (SSI)
时间窗: 30 (+/- 3) days post-surgical procedure
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
次要结局
- Hospital Costs(0 days)
- Hospital Readmission Rates(30 (+/- 3) days post-surgical procedure)
- Length of Hospital Stay(30 (+/- 3) days post-surgical procedure)