A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post-Operative Surgical Site Infections in Colorectal Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Site Infections
研究概览
简要总结
Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line to toes will decrease surgical site infections (SSI) by 30% when compared to patients who receive routine standard of care (use of chlorhexidine cloths night before surgery and morning of surgery).
详细描述
Patients undergoing colorectal surgery will be randomized in a 1:1 fashion into two groups. One will be standard of care using 2% Chlorhexidine Gluconate wipes night before surgery and morning if surgery. The second group will be randomized into the study arm using 2% Chlorhexidine Gluconate clothes from jaw line to toes night before surgery, morning of surgery and daily post operative. Skin cultures will be obtained at time of consent, prior to surgical procedure before surgical scrub and draping, post operative day 4 and at 30 day follow up visit. Incision lines will be assessed daily by study staff for signs of surgical site infection utilizing the CDC's 3 definitions of surgical site infections, superficial incisional SSI, deep incisional SSI, and organ space SSI.
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
- •Patients > 18 years old scheduled for a colorectal surgical procedure ASA>2 OR pre-operatively hospitalized
排除标准
- •Unable to consent
- •Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
- •Current infection or history of abdominal infections.
- •Patients on chronic steroids or immunosuppressive medications.
研究组 & 干预措施
Standard of Care
Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery
干预措施: 2% Chlorohexidine Gluconate Standard of Care (Drug)
Treatment Arm
Patients will perform treatment with 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative until post op day 4 or discharge
干预措施: 2% Chlorohexidine Gluconate Chin to Toe (Drug)
结局指标
主要结局
Incidence of Surgical Site Infections
时间窗: 30 days
Number of participants who had surgical site infection development at 30 day post operative visit based on Center for Disease Control Criteria for Defining A Surgical Site Infection (SSI), 2011.
次要结局
未报告次要终点
研究者
Steven Klintworth
Research Nurse Specialist IV
Vanderbilt University