Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
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. The purpose of this study is to assess whether placement of copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in comparison with non-copper surfaced objects.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Efficacy of Copper in Reducing Health-Acquired Infections and Microbial Burden as Measured on High Touch Surfaces in a Pediatric Intensive Care Unit. A Controlled Clinical Trial.|
- Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
- Microbial Burden measured on high-touch copper and non-copper surfaced objects [ Time Frame: 1 year study duration ] [ Designated as safety issue: No ]Total microbial burden and selected bacteria (MRSA,VRE) will be measured twice a month in all bedrails and sink handles of the PICU study site.
- Incidence of new events of colonization with selected pathogens per 1000 patient-days at risk [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.
|Study Start Date:||November 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
No Intervention: Non copper standard surfaced objects
Rooms assigned to standard surfaced objects
Experimental: Copper-alloy surfaced objects
Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles.
Other: Copper-alloy surfaced objects
Room assigned to the Experimental arm will be furnished with copper-alloy surfaced objects,i.e. bed-rails, bed-rail levers, IV poles, nurse workstation, HCW clipboards, sink handles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678612
|Hospital Roberto del Rio|
|Principal Investigator:||Bettina von Dessauer, MD||Hospital Roberto del Rio|