Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Sponsor

John H. Stroger Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00130221

Collaborator

Sage Products, Inc. (Industry), Centers for Disease Control and Prevention (U.S. Fed)

208

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Infection Bacteremia Sepsis Pneumonia Urinary Tract Infection Clostridium Infection	Drug: 2% chlorhexidine gluconate impregnated cloth	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)

Study Start Date :

Jun 1, 2005

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Clinical: Primary blood stream infections and culture negative sepsis []
Microbiologic: Skin colonization from environment and endotracheal secretions []

Secondary Outcome Measures

Clinical: Laboratory confirmed blood stream infections []
Nosocomial infections []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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