A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 702
- 试验地点
- 2
- 主要终点
- Surgical Site Infection (SSI) Rate
研究概览
简要总结
Surgical site infection (SSI) remains a problem in colorectal surgery. Strategies to reduce the incidence of SSI following colorectal surgery are important to improve overall patient outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical patients.
Preventing contamination of the wound through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing focus to reduce wound infections SSI.
详细描述
Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery with published rates ranging from 7 to 25%. The negative outcomes of SSI are well reported and include a significant increase in morbidity, length of hospital stay, readmissions and healthcare-associated cost. Therefore, strategies to reduce the incidence of SSI following colorectal surgery are important to improve overall patient outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical patients.
Key to the pathogenesis of SSI is the degree of bacterial contamination of the surgical wound. Preventing contamination of the wound or reducing the bacterial load through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing strategic focus to reduce wound infections after surgery.
The usage of intraoperative wound irrigation has been shown to significantly reduce the risk of SSI via multiple RTC. A surgical device that combines continuous wound irrigation and barrier protection will have an important SSI prevention advantage.
CleanCision is a recently developed apparatus that serves this purpose and was found to reduce bacterial wound contamination in preclinical and clinical trials.
This study aims to investigate the effect of using CleanCision wound protector on the rates of postoperative Surgical Site Infections in comparison to the current wound protector (Alexis O) being used at our institute.
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
- Single (Outcomes Assessor)
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
- •Patients 18 years old and above.
- •Elective colorectal surgery with a planned resection including open or laparoscopic surgeries.
- •Clean -contaminated, contaminated and dirty wounds per the definition above.
- •Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB and mechanical bowel preparation.
- •Anticipated incision length of 3-17 cm
排除标准
- •Patients younger than 18 years old.
- •Patients with a preexisting stoma.
- •Patients with prior laparotomy within 15 days.
- •Patients with an active infection or systemic antibiotic therapy within 1 week prior to surgery with the exception of preoperative antimicrobial prophylaxis.
- •Emergent/ urgent surgery.
结局指标
主要结局
Surgical Site Infection (SSI) Rate
时间窗: 30 days
To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector.
次要结局
未报告次要终点
研究者
Scott Steele
President, Main Campus Submarket
The Cleveland Clinic