Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130221
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : April 4, 2007
Sage Products, Inc.
Centers for Disease Control and Prevention
Information provided by:
John H. Stroger Hospital

August 12, 2005
August 15, 2005
April 4, 2007
June 2005
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  • Clinical: Primary blood stream infections and culture negative sepsis
  • Microbiologic: Skin colonization from environment and endotracheal secretions
Same as current
Complete list of historical versions of study NCT00130221 on Archive Site
  • Clinical: Laboratory confirmed blood stream infections
  • Nosocomial infections
  • Clinical: Laboratory confirmed blood stream infections
  • -Clinical: Nosocomial infections
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Not Provided
Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections
Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)
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.

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.

Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Nosocomial Infection
  • Bacteremia
  • Sepsis
  • Pneumonia
  • Urinary Tract Infection
  • Clostridium Infection
Drug: 2% chlorhexidine gluconate impregnated cloth
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2006
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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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IND # 71,948
Not Provided
Not Provided
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John H. Stroger Hospital
  • Sage Products, Inc.
  • Centers for Disease Control and Prevention
Principal Investigator: Robert A Weinstein, MD John H. Stroger Hospital of Cook County
John H. Stroger Hospital
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP