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Completed

NCT Number: NCT02351895

Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use

This is a prospective Infection Control study comparing rates of antibiotic usage and infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens versus regular linens.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

About this study

One ward of the ICU had copper impregnated linen while the other had regular linen. This included sheets, pillowcases, towels and patient gowns. After the first 23 week period was completed, there was a 3 week washout period. After this, the wards were switched with the first using regular linen and the second using copper impregnated linen.

The investigators followed participants and documented any infections >48 hours after admission to the ICU. The number and days of antibiotics used for the infections were also documented. Using assigned study numbers, the investigators obtained demographic data: age, sex, co-morbid conditions, and admitting diagnosis. All participants were followed daily in the GICU and daily for 48 hours after transfer to the regular floor. Date of discharge will be obtained retrospectively. Infection control (IC) routinely obtains Methicillin Resistant Staphylococcus Aureus (MRSA) nasal swabs on all patients on admission to the GICU, once weekly while in GICU and then again on discharge from the GICU. They monitor the GICU patients for healthcare associated infections (HAI) that meet the National Healthcare Safety Network (NHSN) 146 definitions. The NHSN is a widely used HAI tracking system, and the infections documented included Ventilator associated pneumonia (VAP), Catheter related blood stream infections (CLABSI), catheter associate urinary tract infections (CAUTI) and Clostridium difficile associated diarrhea (CDAD). They also obtain information on decubitus ulcers (bed sores) that develop during hospital stay. Infection control also routinely monitors the isolation of multi-drug resistant bacteria, namely Vancomycin Resistant Enterococci (VRE), Extended Spectrum beta Lactamase producing organisms (ESBL) and Carbapenemase producing enterobacteriaceae (CRE) as well as Multi drug resistant (MDR ) Acinetobacter baumanii from cultures. This above information will be obtained from the IC nurses on a weekly basis by the investigators.

As most of the infections in the ICU do not meet strict NHSN criteria, the investigators defined an infection as: the physician diagnosing an infection, and then initiating antibiotics for the same.

Copper linen were implemented the same as regular linen. There was no difference in the nursing or physician staff on either side. No interventions were made other than existing hospital wide IC interventions

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients >18 years and <90 years who were admitted to the GICU during the study period

-

Exclusion criteria

  • Those that did not meet the age criteria as above.
  • Any patients with Menke's syndrome or Wilson's disease
  • Any patient with an allergy to copper or iodine
  • Any patient who wishes to opt out of participating

Treatment and study plan

Copper impregnated linen

Other

Copper impregnated linen was used in place of regular linen on one ward (out of two) for each period of the study. Each study period lasted for 23 weeks. After the washout period (3 weeks) the wards were switched.

Primary outcomes

  1. Antibiotic usage in copper impregnated vs regular linen wards >48 hours after admission to ICU

    Time frame: Two study periods of 23 weeks each

    To assess whether the use of copper impregnated linens was associated with decreased use of antibiotics

Secondary outcomes

  1. Decrease in clinical infection

    Time frame: Two study periods of 23 weeks each

    To assess whether the copper impregnated linen usage was associated with decrease in the number of clinical infections diagnosed by physicians

  2. Decrease in NHSN infection

    Time frame: Two study periods of 23 weeks each

    Secondary measure included whether the copper impregnated linen usage was associated with decrease in the number of NHSN infections as defined by the infection control personnel

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Collaborators

  • Cupron Inc.

Registry information

Official study title

Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use in a Single Intensive Care Unit

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2015
Registry last updated
Aug 5, 2015

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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