Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

This study has been completed.
Sponsor:
Collaborators:
Sage Products, Inc.
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00130221
First received: August 12, 2005
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Nosocomial Infection
Bacteremia
Sepsis
Pneumonia
Urinary Tract Infection
Clostridium Infection
Drug: 2% chlorhexidine gluconate impregnated cloth
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

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

Estimated Enrollment: 208
Study Start Date: June 2005
Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00130221

Locations
United States, Illinois
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Sage Products, Inc.
Investigators
Principal Investigator: Robert A Weinstein, MD John H. Stroger Hospital of Cook County
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00130221     History of Changes
Other Study ID Numbers: 05-006, IND # 71,948
Study First Received: August 12, 2005
Last Updated: April 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by John H. Stroger Hospital:
Chlorhexidine
Blood stream infections
central venous catheter associated
Nosocomial infection
Bacteremia
sepsis
Pneumonia
Urinary tract infection
Clostridium Difficile
intensive care unit
catheter
nosocomial pneumonia
Infection control

Additional relevant MeSH terms:
Bacteremia
Clostridium Infections
Communicable Diseases
Cross Infection
Infection
Pneumonia
Urinary Tract Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Inflammation
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Sepsis
Systemic Inflammatory Response Syndrome
Urologic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014