Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nosocomial Infection, Bacteremia, Sepsis, Pneumonia, Urinary Tract Infection, Clostridium Infection

Intervention / Treatment
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* Drug: 2% chlorhexidine gluconate impregnated cloth
* Other: Daily bathing with Bar soap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine gluconate (CHG)<br>daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage) | Drug: 2% chlorhexidine gluconate impregnated cloth<br> <br> |
| Active Comparator: Soap & Water<br>bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths | Other: Daily bathing with Bar soap<br>* bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.<br>* Other names: Soap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical: Primary blood stream infections and culture negative sepsis | Weekly culture of central line insertion sites | Six Months | 
| Microbiologic: Skin colonization from environment and endotracheal secretions | Weekly skin cultures | Six Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical: Laboratory confirmed blood stream infections | Culture positive blood stream infection from patients on investigational units | Six months | 
| Nosocomial infections | 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). | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteremia, Chlorhexidine, Blood stream infections, central venous catheter associated, Nosocomial infection, sepsis, Pneumonia, Urinary tract infection, Clostridium Difficile, intensive care unit, catheter, nosocomial pneumonia, Infection control