Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- A composite of healthcare-associated infections
研究概览
简要总结
Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.
Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •All patients admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center
排除标准
- •Being cared for in the burn ICU or patients with TEN/SJS or burns being cared for in one of the non-burn intensive care units.
- •Patients with known allergy to chlorhexidine gluconate
- •Age < 18 years old
- •Patients where daily bathing would not be safe
研究组 & 干预措施
Chlorhexidine bathing
Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit.
干预措施: Chlorhexidine bathing (Other)
Non-chlorhexidine bathing
Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit.
干预措施: Non-chlorhexidine bathing (Other)
结局指标
主要结局
A composite of healthcare-associated infections
时间窗: Daily
A composite of the following healthcare-associated infections: 1. Central line-associated blood stream infections (CLABSI) 2. Possible or probable ventilator associated pneumonia (VAP) 3. Catheter-associated urinary tract infection (CAUTI) 4. C. difficile-associated diarrhea
次要结局
- Rates of each individual site infection included in the composite calculation above(Daily)
- Skin reactions(As needed)
- Hospital mortality(One year)
- Hospital length of stay(One year)
- ICU length of stay(One year)
- Rate of cultures positive for multi-drug resistant organisms(Daily)
- Rates of blood culture contamination(Daily)
- Rates of healthcare-acquired bloodstream infections(Daily)
研究者
Michael Noto
Clinical Fellow, Division of Allergy, Pulmonary, and Critical Care Medicine
Vanderbilt University