Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Sepsis Clinical Trial

Official title:

Skin Cleansing With Chlorhexidine to Improve Nosocomial Infection Risks. (SCCIN Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130221
• Other study ID #: 05-006
• Status: Completed
• Phase: Phase 1
• Start date: June 2005
• Est. completion date: July 26, 2006

Study information

• Verified date: June 2023
• Source: Cook County Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 26, 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Clostridium Infection
• Clostridium Infections
• Communicable Diseases
• Cross Infection
• Infections
• Nosocomial Infection
• Pneumonia
• Sepsis
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• 2% chlorhexidine gluconate impregnated cloth

Other:
• Daily bathing with Bar soap
bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.

Locations

Country	Name	City	State
United States	John H. Stroger Hospital of Cook County	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Cook County Health	Centers for Disease Control and Prevention, Sage Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical: Primary blood stream infections and culture negative sepsis	Weekly culture of central line insertion sites	Six Months
Primary	Microbiologic: Skin colonization from environment and endotracheal secretions	Weekly skin cultures	Six Months
Secondary	Clinical: Laboratory confirmed blood stream infections	Culture positive blood stream infection from patients on investigational units	Six months
Secondary	Nosocomial infections	Positive microbiology lab results of Clostridium difficile-associated diarrhea (CDAD), secondary bloodstream infection (BSI), ventilator-associated pneumonia (VAP), urinary tract infection (UTI), and clinical cultures that grew selected resistant bacteria (MRSA, VRE, and A. baumannii).	Six months