Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

NCT00130221 | Completed Phase 1

• 1 other identifier: 05-006
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Nosocomial Infection; Bacteremia; Sepsis; Pneumonia; Urinary Tract Infection; Clostridium Infection

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinical: Laboratory confirmed blood stream infections

  Six months

• Nosocomial infections

  Six months

Study Arms (2)

chlorhexidine gluconate (CHG)

EXPERIMENTAL

daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)

Drug: 2% chlorhexidine gluconate impregnated cloth

Soap & Water

ACTIVE COMPARATOR

bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths

Other: Daily bathing with Bar soap

Interventions

2% chlorhexidine gluconate impregnated cloth DRUG

chlorhexidine gluconate (CHG)

Daily bathing with Bar soap OTHER

bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.

Also known as: Soap

Soap & Water

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook County Health: lead
• Sage Products, Inc.: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• 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. doi: 10.1034/j.1399-6576.2001.045006710.x.

  PMID: 11421829 BACKGROUND

• 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. doi: 10.1093/clind/24.4.704.

  PMID: 9145745 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000129973.13104.2d.

  PMID: 15241096 BACKGROUND

• 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. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.

  PMID: 11303260 BACKGROUND

• 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. doi: 10.1067/mic.2002.129427.

  PMID: 12461511 BACKGROUND

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

  PMID: 12853534 BACKGROUND

• 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. doi: 10.1001/archinte.167.19.2073.

  PMID: 17954801 DERIVED

MeSH Terms

Conditions

Cross Infection; Bacteremia; Sepsis; Pneumonia; Urinary Tract Infections; Clostridium Infections; Healthcare-Associated Pneumonia

Interventions

Soaps

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Gram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Robert A Weinstein, MD

  John H. Stroger Hospital of Cook County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: June 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: July 26, 2006
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)