Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections

NCT ID: NCT00779246

Last Updated: 2018-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-07-31

Brief Summary

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This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).

Detailed Description

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Conditions

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Staphylococcal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation.

Group Type ACTIVE_COMPARATOR

Nasal swabs for MRSA culture

Intervention Type OTHER

Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.

Contact isolation

Intervention Type OTHER

All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.

2

Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures (ASC) will also be used in this arm, but results will be blinded and not used to determine whether patients should be in contact isolation.

Group Type ACTIVE_COMPARATOR

Nasal swabs for MRSA culture

Intervention Type OTHER

Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.

Chlorhexidine gluconate

Intervention Type DRUG

CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study.

Interventions

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Nasal swabs for MRSA culture

Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.

Intervention Type OTHER

Chlorhexidine gluconate

CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study.

Intervention Type DRUG

Contact isolation

All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.

Intervention Type OTHER

Other Intervention Names

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Sage 2% Chlorhexidine gluconate cloth

Eligibility Criteria

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Inclusion Criteria

* All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion

Exclusion Criteria

* Patient refusal
* Contraindication to nasal swabbing (arm 1)
* Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sage Products, Inc.

INDUSTRY

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marci Drees, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Hospital

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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28116

Identifier Type: -

Identifier Source: org_study_id

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