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

Healthcare-acquired Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565798
• Other study ID #: DOD W81XWH-07-C-0053
• Secondary ID: Effect of Copper
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: March 23, 2016
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthcare-acquired Infection
• Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Memorial Sloan Kettering Cancer Center, Ralph H. Johnson VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No