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

Overview

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).

Full Title of Study: “Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: 2% Chlorhexidine gluconate cloth
    • Daily bathing

Arms, Groups and Cohorts

  • Experimental: 1
    • Daily bathing with 2% chlorhexidine gluconate
  • No Intervention: 2
    • Standard bathing with soap and water basin or disposable cloth

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • Sage Products, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Trish M Perl, MD MSc, Principal Investigator, Johns Hopkins University
    • Aaron Milstone, MD MHS, Study Chair, Johns Hopkins University

Citations Reporting on 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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