Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Clinical: Primary blood stream infections and culture negative sepsis
研究概览
简要总结
Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.
详细描述
Patients admitted to the medical intensive care unit at John H Stroger Hospital are randomly assigned to Unit A or B. Unit B was randomly selected as the intervention unit. For 6 months, all patients in Unit B will be bathed with the 2% CHG Antiseptic Cloth system and all patients in Unit A will receive soap and water baths. After this 6 month period, there will be a 2 to 4 week washout period and the interventions will cross over, with Unit A receiving Chlorhexidine baths and unit B receiving soap and water for 6 months.
Each week, two randomly selected patients will have cultures of the inguinal area, neck/subclavian region, and endotracheal aspirates. A comparison of the colonization of the skin and sputum will be done between the two intervention groups.
Daily infection surveillance will be done on all patients in the intensive care unit. A comparison of blood stream infections, clinical sepsis, and other nosocomial infections will be done between the two intervention groups.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Data collection will be compiled from all the participants admitted to the Medical Intensive Care Unit (MICU).
- •For skin cultures: One randomly selected (intubated or non-intubated) patient in each intervention group
排除标准
- •Patients with greater than 20% of body surface area disruption in skin integrity will be excluded from participation in the 2% CHG Antiseptic Cloths arm of the study
研究组 & 干预措施
chlorhexidine gluconate (CHG)
daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)
干预措施: 2% chlorhexidine gluconate impregnated cloth (Drug)
Soap & Water
bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths
干预措施: Daily bathing with Bar soap (Other)
结局指标
主要结局
Clinical: Primary blood stream infections and culture negative sepsis
时间窗: Six Months
Weekly culture of central line insertion sites
Microbiologic: Skin colonization from environment and endotracheal secretions
时间窗: Six Months
Weekly skin cultures
次要结局
- Clinical: Laboratory confirmed blood stream infections(Six months)
- Nosocomial infections(Six months)
研究者
Pamela Gonzalez Sr Director Clinical Research Office
Clinical Research Director
Cook County Health