Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT00549393

Recruitment Status : Completed

First Posted : October 25, 2007

Results First Posted : October 2, 2015

Last Update Posted : June 14, 2017

Sponsor:

Collaborator:

Sage Products, Inc.

Information provided by (Responsible Party):

Johns Hopkins University

Study Description

Brief Summary:

The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

Condition or disease	Intervention/treatment	Phase
Nosocomial Infections	Drug: 2% Chlorhexidine gluconate cloth	Phase 2 Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5659 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Study Start Date :	February 2008
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorhexidine Chlorhexidine acetate Sodium gluconate Copper gluconate Chlorhexidine hydrochloride Manganese gluconate Chlorhexidine gluconate Hibiclens

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Daily bathing with 2% chlorhexidine gluconate	Drug: 2% Chlorhexidine gluconate cloth Daily bathing
No Intervention: 2 Standard bathing with soap and water basin or disposable cloth

Outcome Measures

Primary Outcome Measures :

Bacteremia [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ]
incidence of bacteremia comparing those in treatment and control groups

Secondary Outcome Measures :

Central Line Associated-bloodstream Infection (CLABSI) [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ]
Comparing incidence of central line-associated bloodstream infections between treatment and control groups

Other Outcome Measures:

Bacteremia [ Time Frame: duration of ICU stay, median 3 days ]
per protocol analysis of incidence of bacteremia comparing those in treatment and control groups

Eligibility Criteria

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Ages Eligible for Study:	2 Months to 25 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients in pediatric intensive care unit

Exclusion Criteria:

Patients with a history of an allergic reaction to chlorhexidine
Patients less than 2 months of age
Patients with severe skin disease or burn
Patients with an indwelling epidural catheter or lumbar drain

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549393

Locations

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United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Missouri
Saint Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Johns Hopkins University

Sage Products, Inc.

Investigators

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Principal Investigator:	Trish M Perl, MD MSc	Johns Hopkins University
Study Chair:	Aaron Milstone, MD MHS	Johns Hopkins University

More Information

Publications of Results:

Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.

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Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00549393
Other Study ID Numbers:	NA_00006799
First Posted:	October 25, 2007 Key Record Dates
Results First Posted:	October 2, 2015
Last Update Posted:	June 14, 2017
Last Verified:	May 2017

Keywords provided by Johns Hopkins University:


intensive care unit Healthcare associated infections (HAI) pediatric

Additional relevant MeSH terms:

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Infections Communicable Diseases Cross Infection Disease Attributes Pathologic Processes Iatrogenic Disease	Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents

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