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Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Primary Purpose

Nosocomial Infection, Bacteremia, Sepsis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
2% chlorhexidine gluconate impregnated cloth
Daily bathing with Bar soap
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John H. Stroger Hospital of Cook County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chlorhexidine gluconate (CHG)

Soap & Water

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical: Primary blood stream infections and culture negative sepsis
Weekly culture of central line insertion sites
Microbiologic: Skin colonization from environment and endotracheal secretions
Weekly skin cultures

Secondary Outcome Measures

Clinical: Laboratory confirmed blood stream infections
Culture positive blood stream infection from patients on investigational units
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).

Full Information

First Posted
August 12, 2005
Last Updated
June 14, 2023
Sponsor
Cook County Health
Collaborators
Sage Products, Inc., Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00130221
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
July 26, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
Collaborators
Sage Products, Inc., Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chlorhexidine gluconate (CHG)
Arm Type
Experimental
Arm Description
daily skin cleansing with no-rinse, 2% CHG-impregnated cloths (Sage)
Arm Title
Soap & Water
Arm Type
Active Comparator
Arm Description
bathing daily with bar soap (Dial Corp., Scottsdale, AZ) warm water, and cotton washcloths
Intervention Type
Drug
Intervention Name(s)
2% chlorhexidine gluconate impregnated cloth
Intervention Type
Other
Intervention Name(s)
Daily bathing with Bar soap
Other Intervention Name(s)
Soap
Intervention Description
bathed daily with bar soap (Dial Corp., Scottsdale, AZ), warm water, and cotton washcloths.
Primary Outcome Measure Information:
Title
Clinical: Primary blood stream infections and culture negative sepsis
Description
Weekly culture of central line insertion sites
Time Frame
Six Months
Title
Microbiologic: Skin colonization from environment and endotracheal secretions
Description
Weekly skin cultures
Time Frame
Six Months
Secondary Outcome Measure Information:
Title
Clinical: Laboratory confirmed blood stream infections
Description
Culture positive blood stream infection from patients on investigational units
Time Frame
Six months
Title
Nosocomial infections
Description
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).
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Weinstein, MD
Organizational Affiliation
John H. Stroger Hospital of Cook County
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H. Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11421829
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.
Results Reference
background
PubMed Identifier
9145745
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.
Results Reference
background
PubMed Identifier
15241096
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.
Results Reference
background
PubMed Identifier
11303260
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.
Results Reference
background
PubMed Identifier
12461511
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.
Results Reference
background
PubMed Identifier
12853534
Citation
Shorr AF, Humphreys CW, Helman DL. New choices for central venous catheters: potential financial implications. Chest. 2003 Jul;124(1):275-84.
Results Reference
background
PubMed Identifier
17954801
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.
Results Reference
derived

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Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

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