Bacteremia, Clostridium Infection, Nosocomial Infection, Pneumonia, Sepsis, Urinary Tract Infection
Conditions
Keywords
Chlorhexidine, Blood stream infections, central venous catheter associated, Nosocomial infection, Bacteremia, sepsis, Pneumonia, Urinary tract infection, Clostridium Difficile, intensive care unit, catheter, nosocomial pneumonia, Infection control
Brief summary
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.
Detailed description
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.
Interventions
DRUG2% chlorhexidine gluconate impregnated cloth
OTHERDaily bathing with Bar soap
bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.
Sponsors
Sage Products, Inc.
Centers for Disease Control and Prevention
Cook County Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical: Primary blood stream infections and culture negative sepsis | Six Months | Weekly culture of central line insertion sites |
| Microbiologic: Skin colonization from environment and endotracheal secretions | Six Months | Weekly skin cultures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical: Laboratory confirmed blood stream infections | Six months | Culture positive blood stream infection from patients on investigational units |
| Nosocomial infections | Six months | Positive microbiology lab results of Clostridium difficile-associated diarrhea (CDAD), secondary bloodstream infection (BSI), ventilator-associated pneumonia (VAP), urinary tract infection (UTI), and clinical cultures that grew selected resistant bacteria (MRSA, VRE, and A. baumannii). |
Countries
United States
Outcome results
None listed