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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:
ClinicalTrials.gov Identifier:
NCT00549393
First Posted: October 25, 2007
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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 Intervention Phase
Nosocomial Infections Drug: 2% Chlorhexidine gluconate cloth Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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


Enrollment: 5659
Study Start Date: February 2008
Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00549393     History of Changes
Other Study ID Numbers: NA_00006799
First Submitted: October 24, 2007
First Posted: October 25, 2007
Results First Submitted: March 31, 2015
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:
Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents