Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
|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: NCT01678612|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : April 10, 2014
|Condition or disease||Intervention/treatment|
|Nosocomial Infections||Other: Copper-alloy surfaced objects|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1012 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
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.
- 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 ]
- Microbial Burden measured on high-touch copper and non-copper surfaced objects [ Time Frame: 1 year study duration ]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 ]Patients with negative culture (from skin and mucosa samples) will be sampled at Day 3, Day 6 and discharge.
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): NCT01678612
|Hospital Roberto del Rio|
|Principal Investigator:||Bettina von Dessauer, MD||Hospital Roberto del Rio|