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

This study has been completed.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Trish Perl, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00549393
First received: October 24, 2007
Last updated: September 1, 2015
Last verified: September 2015

October 24, 2007
September 1, 2015
February 2008
December 2010   (final data collection date for primary outcome measure)
Bacteremia [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ] [ Designated as safety issue: No ]
incidence of bacteremia comparing those in treatment and control groups
Not Provided
Complete list of historical versions of study NCT00549393 on ClinicalTrials.gov Archive Site
Central Line Associated-bloodstream Infection (CLABSI) [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ] [ Designated as safety issue: No ]
Comparing incidence of central line-associated bloodstream infections between treatment and control groups
Not Provided
Bacteremia [ Time Frame: duration of ICU stay, median 3 days ] [ Designated as safety issue: No ]
per protocol analysis of incidence of bacteremia comparing those in treatment and control groups
Not Provided
 
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
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).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Nosocomial Infections
Drug: 2% Chlorhexidine gluconate cloth
Daily bathing
  • Experimental: 1
    Daily bathing with 2% chlorhexidine gluconate
    Intervention: Drug: 2% Chlorhexidine gluconate cloth
  • No Intervention: 2
    Standard bathing with soap and water basin or disposable cloth
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5659
June 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
2 Months to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00549393
NA_00006799
No
Not Provided
Not Provided
Trish Perl, Johns Hopkins University
Johns Hopkins University
Sage Products, Inc.
Principal Investigator: Trish M Perl, MD MSc Johns Hopkins University
Study Chair: Aaron Milstone, MD MHS Johns Hopkins University
Johns Hopkins University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP