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Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Phase 1
Completed
Conditions
Nosocomial Infection
Bacteremia
Sepsis
Pneumonia
Urinary Tract Infection
Clostridium Infection
Interventions
Other: Daily bathing with Bar soap
Registration Number
NCT00130221
Lead Sponsor
Cook County Health
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
208
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
chlorhexidine gluconate (CHG)2% chlorhexidine gluconate impregnated clothdaily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)
Soap & WaterDaily bathing with Bar soapbathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths
Primary Outcome Measures
NameTimeMethod
Clinical: Primary blood stream infections and culture negative sepsisSix Months

Weekly culture of central line insertion sites

Microbiologic: Skin colonization from environment and endotracheal secretionsSix Months

Weekly skin cultures

Secondary Outcome Measures
NameTimeMethod
Clinical: Laboratory confirmed blood stream infectionsSix months

Culture positive blood stream infection from patients on investigational units

Nosocomial infectionsSix 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).

Trial Locations

Locations (1)

John H. Stroger Hospital of Cook County

🇺🇸

Chicago, Illinois, United States

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