An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions From Intraoperative Contamination When Used During Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 14
- 主要终点
- Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
研究概览
简要总结
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at the wound incision site when the CleanCision is used during surgery.
详细描述
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate bacterial contamination at the wound incision site when the CleanCision is used during surgery. The CleanCision is a surgical tool that is designed to be used for the primary purpose of protecting the wound from contamination that occurs to the incision site during surgery ultimately reducing the occurrence of Surgical Site Infections (SSI).
This is a prospective, multi-center, single-arm (non-randomized) clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age 18 and older
- •BMI 15-45, inclusive
- •Colorectal surgery patient, planned resection
- •Incision length meets labeling requirements
- •Written informed consent using the governing IRB approved form
排除标准
- •Patients with a pre-existing stoma
- •Patients undergoing emergent colorectal surgery
- •Known history of contact hypersensitivity or allergy to device materials
- •Prior laparotomy or abdominal surgery within a timeframe that may present a safety risk or compromise study results
- •Active infection, sepsis or systemic antibiotic therapy within timeframe that may impact safety or study results
- •Active participation in any other clinical study of an experimental drug or device that may impact safety or study results
- •Postsurgical life expectancy is less than the study follow up period
- •Subject is pregnant or lactating
- •Subject is under incarceration
- •Subject considered to be inoperable following exploratory surgery
研究组 & 干预措施
Treatment Group
All study subjects will be treated using the CleanCision device.
干预措施: CleanCision (Device)
结局指标
主要结局
Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
时间窗: 1 day (end of the procedure and removal of the investigational device)
Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
Safety (Serious Adverse Events Directly Attributable to the Device)
时间窗: 30 days
Incidence of Serious Adverse Events directly attributable to the device
次要结局
- Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)(1 day (end of the procedure and removal of the investigational device))