NCT01905397已完成不适用
Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- Participants With a Surgical Site Infection
研究概览
简要总结
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Female and male patients 18 years of age or older
- •Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
排除标准
- •The need for emergency surgery.
- •The need for use of only laparoscopic surgery.
- •Presence of bowel obstruction, strangulation, peritonitis or perforation.
- •The presence of local or systemic infection preoperatively.
- •ASA class ≥
- •Inability to provide informed consent and authorization.
- •Known allergy or hypersensitivity to silver.
- •Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.
结局指标
主要结局
Participants With a Surgical Site Infection
时间窗: 30 days after surgery; assessed at 4-5 days and 30 days post-operation
Number and percentage of participants with at least 1 surgical site infection (SSI).
次要结局
- Number of Surgical Site Infections by Type(30 days post-surgery)
- Length of Hospital Stay(Up to 62 days post-surgery)
研究者
研究点 (4)
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