Clinical trial NCT00130221: Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections
Official title: Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
Collaborators: name: Sage Products, Inc.
name: Centers for Disease Control and Prevention
First posted: 2005-08-15
Enrollment: 208
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Clinical: Primary blood stream infections and culture negative sepsis
timeFrame: Six Months
measure: Microbiologic: Skin colonization from environment and endotracheal secretions
timeFrame: Six Months
Secondary outcomes:
measure: Clinical: Laboratory confirmed blood stream infections
timeFrame: Six months
measure: Nosocomial infections
timeFrame: Six months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger Hospital of Cook County
state: Illinois
Study officials:
affiliation: John H. Stroger Hospital of Cook County
name: Robert A Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Shorr AF, Humphreys CW, Helman DL. New choices for central venous catheters: potential financial implications. Chest. 2003 Jul;124(1):275-84.
citation: 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.