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Efficacy Of Copper To Reduce Acquisition Of Microbes and Healthcare-acquired Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565798
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 24, 2016
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Ralph H. Johnson VA Medical Center
Information provided by (Responsible Party):
Medical University of South Carolina

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.


Condition or disease Intervention/treatment Phase
Healthcare-acquired Infection Other: Copper-alloy surfaced patient care objects Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Copper Surfaced Room
Patients sequentially randomized to this arm were admitted to an ICU room with copper surfaced objects.
Other: Copper-alloy surfaced patient care objects
Copper-alloy surfaced bed rails, over bed tray tables, chair arms, nurse call devices, laptop and computer monitor bezels, and IV poles were placed into the patient ICU rooms.

No Intervention: Standard Surfaced Room
Patients sequentially randomized to this arm were admitted to an ICU room with standard surfaced objects



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Microbial burden and risk of HAI [ Time Frame: July 2010 to June 2011 (up to 1 year) ]
    The risk of HAI among patients admitted to ICU will be assessed by microbial burden of environment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565798


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Memorial Sloan Kettering Cancer Center
Ralph H. Johnson VA Medical Center
Investigators
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Principal Investigator: Michael G Schmidt, PhD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01565798    
Other Study ID Numbers: DOD W81XWH-07-C-0053
Effect of Copper on HAI ( Other Grant/Funding Number: U.S. Army Material Command Contract W81XWH-07-C-0053 )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: December 2011
Keywords provided by Medical University of South Carolina:
healthcare-acquired infections
colonization
copper-alloy surfaces
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs