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

NCT02351895 | Completed

• 1 other identifier: 13-08-FB-0171
• Study Type: observational
• Target: 1,302
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Acquired Infection

Keywords

infection control; Prevention of hospital acquired infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Decrease in clinical infection

  Two study periods of 23 weeks each

• Decrease in NHSN infection

  Two study periods of 23 weeks each

Study Arms (1)

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

Other: Copper impregnated linen

Interventions

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.

Copper linens

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Cupron Inc.: collaborator

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (3)

• 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.

  PMID: 23571374 BACKGROUND

• 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.

  PMID: 23571364 BACKGROUND

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

  PMID: 12041959 BACKGROUND

Related Links

• NHSN infection definition

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shivanjali Shankaran, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine, Division of Infectious Diseases

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

US (1)