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Completed

NCT Number: NCT01678612

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.

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Key information

Conditions

Nosocomial Infections Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

7 day–180 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Roberto del Rio

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient admitted to PICU
  • stay at PICU > 24 hours
  • informed consent by parent/legal representative

Exclusion criteria

none

Treatment and study plan

Copper-alloy surfaced objects

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Codelco

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2012
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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