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

Hospital Acquired Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351895
• Other study ID #: 13-08-FB-0171
• Status: Completed
• Phase: N/A
• First received: January 27, 2015
• Last updated: August 4, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1302
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Hospital Acquired Infection
• Infection

Intervention

Other:
• Copper impregnated linen
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.

Locations

Country	Name	City	State
United States	Sentara Norfolk General Hospital	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	Cupron Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bilian X. Intrauterine devices. Best Pract Res Clin Obstet Gynaecol. 2002 Apr;16(2):155-68. Review. — View Citation

Salgado CD, Sepkowitz KA, John JF, Cantey JR, Attaway HH, Freeman KD, Sharpe PA, Michels HT, Schmidt MG. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013 May;34(5):479-86. doi: 10.1086/670207. — View Citation

Schmidt MG, Attaway Iii HH, Fairey SE, Steed LL, Michels HT, Salgado CD. Copper continuously limits the concentration of bacteria resident on bed rails within the intensive care unit. Infect Control Hosp Epidemiol. 2013 May;34(5):530-3. doi: 10.1086/670224. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic usage in copper impregnated vs regular linen wards >48 hours after admission to ICU	To assess whether the use of copper impregnated linens was associated with decreased use of antibiotics	Two study periods of 23 weeks each	No
Secondary	Decrease in clinical infection	To assess whether the copper impregnated linen usage was associated with decrease in the number of clinical infections diagnosed by physicians	Two study periods of 23 weeks each	No
Secondary	Decrease in NHSN infection	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	Two study periods of 23 weeks each	No

External Links

•   NHSN infection definition