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

NCT ID: NCT02351895

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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

Conditions

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Hospital Acquired Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Copper linens

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

Copper impregnated linen

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cupron Inc.

INDUSTRY

Sponsor Role collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role lead

Responsible Party

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SShankaran

Assistant Professor, Internal Medicine, Division of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shivanjali Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23571374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23571364 (View on PubMed)

Bilian X. Intrauterine devices. Best Pract Res Clin Obstet Gynaecol. 2002 Apr;16(2):155-68. doi: 10.1053/beog.2002.0267.

Reference Type BACKGROUND
PMID: 12041959 (View on PubMed)

Related Links

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Other Identifiers

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13-08-FB-0171

Identifier Type: -

Identifier Source: org_study_id

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