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

NCT01565798 | Completed DMC

• 2 other identifiers: DOD W81XWH-07-C-0053Effect of Copper on HAI
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare-acquired Infection

Keywords

healthcare-acquired infections; colonization; copper-alloy surfaces

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbial burden and risk of HAI

  July 2010 to June 2011 (up to 1 year)

Study Arms (2)

Copper Surfaced Room

EXPERIMENTAL

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

Other: Copper-alloy surfaced patient care objects

Standard Surfaced Room

NO INTERVENTION

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

Interventions

Copper-alloy surfaced patient care objects OTHER

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.

Copper Surfaced Room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• less than 18 years of age or
• pregnant

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Ralph H. Johnson VA Medical Center: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Michael G Schmidt, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 29, 2012
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 24, 2016

Record last verified: 2011-12

Locations

US (1)