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

Nosocomial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549393
• Other study ID #: NA_00006799
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 24, 2007
• Last updated: September 1, 2015
• Start date: February 2008
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5659
• Est. completion date: June 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 25 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infections

Intervention

Drug:
• 2% Chlorhexidine gluconate cloth
Daily bathing

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Saint Louis Children's Hospital	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Sage Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, crossov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bacteremia	per protocol analysis of incidence of bacteremia comparing those in treatment and control groups	duration of ICU stay, median 3 days	No
Primary	Bacteremia	incidence of bacteremia comparing those in treatment and control groups	participants were followed for the duration of ICU stay, median stay 3 days	No
Secondary	Central Line Associated-bloodstream Infection (CLABSI)	Comparing incidence of central line-associated bloodstream infections between treatment and control groups	participants were followed for the duration of ICU stay, median stay 3 days	No