Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Cook County Health

Status and phase: Completed; Phase 1

Conditions: Clostridium Infection; Nosocomial Infection; Urinary Tract Infection; Bacteremia; Pneumonia; Sepsis

Treatments: Other: Daily bathing with Bar soap; Drug: 2% chlorhexidine gluconate impregnated cloth

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00130221

05-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

chlorhexidine gluconate (CHG)

Experimental group

Description:

daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)

Treatment:

Drug: 2% chlorhexidine gluconate impregnated cloth

Soap & Water

Active Comparator group

Description:

bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths

Treatment:

Other: Daily bathing with Bar soap