A Randomized Double-Blind Study of 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol vs Iodine Povacrylex [0.7% Available Iodine] / 74% Isopropyl Alcohol for Perioperative Skin Preparation in Open Elective Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 3
- 主要终点
- The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
研究概览
简要总结
Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
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
- Double (Participant, 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
- 是
入选标准
- •18 years or older, male or female
- •Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
- •A clean-contaminated preoperative classification.
- •Patient must have decision-making capacity and undergo appropriate informed consent process.
- •Non-pregnant or post menopausal or surgically sterilized females. If of child-bearing age, patients must have a negative (serum or urine) pregnancy prior to surgery.
排除标准
- •Antibiotics taken within 5 days prior to surgery.
- •Infected wound classification.
- •Preoperative evaluation that may preclude full closure of the skin.
- •Undergoing any bowel procedure that will not result in an extraction incision.
- •Ongoing radiation or chemotherapy treatment.
- •Refusal to accept medically indicated blood products.
- •Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy.
- •History of laparotomy within the last 60 days.
- •Known allergy to iodine or to chlorhexidine gluconate.
- •Participating in a preoperative antibiotic trial.
- •Participating in a skin antisepsis trial.
- •Participating in Ulcerative colitis trial conflicting with this trial.
- •Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).
研究组 & 干预措施
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Preoperative Skin Antisepsis Preparation
干预措施: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol (Drug)
Iodine Povacrylex/74% Isopropyl Alcohol
Preoperative Skin Antisepsis Preparation
干预措施: Iodine Povacrylex/74% Isopropyl Alcohol (Drug)
结局指标
主要结局
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
时间窗: within 35 days of randomization to treatment assignment
The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex \[0.7% available Iodine\] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.
次要结局
- Time to Develop Surgical Site Infection(within 35 days of randomization to treatment assignment)
- Number and Percentage of Participants With Deep Wound Infection(within 35 days of randomization to treatment assignment)
- Number and Percentage of Participants With Organ Space Infection(within 35 days of randomization to treatment assignment)
- Bacterial Pathogens Present in Documented Surgical Site Infection(within 35 days of randomization to treatment assignment)
- Length of Hospital Stay(within 35 days of randomization to treatment assignment)