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

NCT ID: NCT00549393

Last Updated: 2017-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5659 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Nosocomial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Daily bathing with 2% chlorhexidine gluconate

Group Type EXPERIMENTAL

2% Chlorhexidine gluconate cloth

Intervention Type DRUG

Daily bathing

2

Standard bathing with soap and water basin or disposable cloth

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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2% Chlorhexidine gluconate cloth

Daily bathing

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sage Products, Inc.

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trish M Perl, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Aaron Milstone, MD MHS

Role: STUDY_CHAIR

Johns Hopkins University

Locations

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Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Saint Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23363666 (View on PubMed)

Other Identifiers

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NA_00006799

Identifier Type: -

Identifier Source: org_study_id

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