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Clinical Trials/NCT01565798
NCT01565798CompletedNot Applicable

Copper Antimicrobial Research Program: Environmental and Patient Sampling For Indicator Organisms To Determine The Efficacy Of Copper To Reduce Acquisition Of Microbes From The Patient Care Environment

Medical University of South Carolina1 site in 1 country614 target enrollmentStarted: July 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
614
Locations
1
Primary Endpoint
Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.

Study Overview

Brief Summary

CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality. Commonly touched items in the patient care environment harbor microorganisms that may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a theoretical advantage to conventional cleaning, as disinfection is continuous rather than episodic.

OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care unit (ICU) reduce risk of HAI.

DESIGN: An intention to treat study where patients are sequentially placed into rooms with or without copper-alloy surfaced objects.

SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer center, and a Veteran's Administration Medical Center.

PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study hospital is eligible for placement into a study room if available.

INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients 18 years and older requiring admission to an ICU at one of the study sites were eligible

Exclusion Criteria

  • •less than 18 years of age or

Arms & Interventions

Copper Surfaced Room

Experimental

Patients sequentially randomized to this arm were admitted to an ICU room with copper surfaced objects.

Intervention: Copper-alloy surfaced patient care objects (Other)

Standard Surfaced Room

No Intervention

Patients sequentially randomized to this arm were admitted to an ICU room with standard surfaced objects

Outcomes

Primary Outcomes

Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.

Time Frame: July 2010 to June 2011 (up to 1 year)

Patients prospectively followed from ICU admission to hospital discharge for acquisition of HAI and/or colonization with MRSA or VRE

Secondary Outcomes

  • Microbial burden and risk of HAI(July 2010 to June 2011 (up to 1 year))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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