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

Completed

• Conditions: Hospital Acquired Infection
• Interventions: Other: Copper impregnated linen

• Registration Number: NCT02351895
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1302

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Copper linens	Copper impregnated linen	One ward during each period (23 weeks each) used copper impregnated linen on the bed and as patient gowns. The second ward used regular linen on the bed and as patient gowns

Primary Outcome Measures

Name	Time	Method
Antibiotic usage in copper impregnated vs regular linen wards >48 hours after admission to ICU	Two study periods of 23 weeks each	To assess whether the use of copper impregnated linens was associated with decreased use of antibiotics

Secondary Outcome Measures

Name	Time	Method
Decrease in clinical infection	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
Decrease in NHSN infection	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

Trial Locations

Locations (1)

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States