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

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

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 Overview

• Status: Completed
• Conditions: Healthcare-acquired Infection
• Intervention / Treatment: Other: Copper-alloy surfaced patient care objects

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.	Patients prospectively followed from ICU admission to hospital discharge for acquisition of HAI and/or colonization with MRSA or VRE	July 2010 to June 2011 (up to 1 year)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Memorial Sloan Kettering Cancer Center; Ralph H. Johnson VA Medical Center
• Investigators: Principal Investigator: Michael G Schmidt, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: colonization; healthcare-acquired infections; copper-alloy surfaces
• Additional Relevant MeSH Terms: Infections; Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• 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)