Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections - Full Text View

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:

MedlinePlus related topics: Pneumonia Sepsis Urinary Tract Infections

Drug Information available for: Chlorhexidine Sodium gluconate Manganese gluconate Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

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

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.

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Robert A Weinstein, MD

John H. Stroger Hospital of Cook County

More Information

Publications:

Appelgren P, Hellstrom I, Weitzberg E, Soderlund V, Bindslev L, Ransjo U. Risk factors for nosocomial intensive care infection: a long-term prospective analysis. Acta Anaesthesiol Scand. 2001 Jul;45(6):710-9.

Beezhold DW, Slaughter S, Hayden MK, Matushek M, Nathan C, Trenholme GM, Weinstein RA. Skin colonization with vancomycin-resistant enterococci among hospitalized patients with bacteremia. Clin Infect Dis. 1997 Apr;24(4):704-6.

Cohen J, Cristofaro P, Carlet J, Opal S. New method of classifying infections in critically ill patients. Crit Care Med. 2004 Jul;32(7):1510-26. Review.

Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. Epub 2001 Apr 3. Review. No abstract available.

O'grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2002 Dec;30(8):476-89. Review.

Shorr AF, Humphreys CW, Helman DL. New choices for central venous catheters: potential financial implications. Chest. 2003 Jul;124(1):275-84.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bleasdale SC, Trick WE, Gonzalez IM, Lyles RD, Hayden MK, Weinstein RA. Effectiveness of chlorhexidine bathing to reduce catheter-associated bloodstream infections in medical intensive care unit patients. Arch Intern Med. 2007 Oct 22;167(19):2073-9.

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
Pneumonia
Sepsis
Urinary Tract Infections
Cross Infection
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections

Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013