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

Phase 2

Completed

• Conditions: Nosocomial Infections
• Interventions: Drug: 2% Chlorhexidine gluconate cloth

• Registration Number: NCT00549393
• Lead Sponsor: Johns Hopkins University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-25
• Study Start: 2008-02
• Primary Completion: 2010-12
• Study Completion: 2012-06
• Results First Submitted: 2015-03-31
• Results First Submitted QC: 2015-09-01
• Results First Posted: 2015-10-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5659

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	2% Chlorhexidine gluconate cloth	Daily bathing with 2% chlorhexidine gluconate

Primary Outcome Measures

Name	Time	Method
Bacteremia	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

Name	Time	Method
Central Line Associated-bloodstream Infection (CLABSI)	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

Trial Locations

Locations (5)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Saint Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's National Medical Center; 🇺🇸 Washington, D.C., District of Columbia, United States