Bacterial Contamination of Healthcare Worker Uniforms

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Denver Health and Hospital Authority
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01537835
First received: February 17, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

Healthcare worker uniforms are frequently contaminated with bacteria known to cause infections in humans. These bacteria are acquired during the workday. A new technology of antimicrobial textiles have been developed and incorporated into the fabric of health care worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial properties in the clinical setting. Because of the potential benefit that such uniforms could offer HCWs and patients alike, further investigation into whether these fabrics are effective is warranted.

Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards will be invited to participate in this study. Participants will be randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform and each subject's wrist area will be cultured to assess for total bacterial colonization as well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.

Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial contamination than standard uniforms (scrubs) at the end of an 8-hour workday.

Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial contamination of sites swabbed compared to standard uniform after an 8-hour workday.

Specific aim 1b. Demonstrate that antimicrobial uniforms will have less antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour workday.


Condition Intervention
Bacterial Contamination of Healthcare Worker Uniforms
Other: Antimicrobial Scrubs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Bacterial Contamination of Healthcare Worker Uniforms: A Study of Antimicrobial Uniforms on Occupationally Acquired Bacterial Contamination: A Randomized Controlled Trial

Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Total bacterial contamination of HCW worker uniform with antimicrobial properties compared to standard HCW uniform after an 8-hour workday. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess for methicillin resistent Staphylococcus aureus, vancomycin resistant enterococci, and gram-negative bacterial contamination on HCW uniform with antimicrobial properties compared to standard HCW uniform. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Scrubs
Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
Experimental: Antimicrobial Scrubs 1
Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Other: Antimicrobial Scrubs
Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
Experimental: Antimicrobial Scrubs 2
Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.
Other: Antimicrobial Scrubs
Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards;
  • Provider must be available for cultures at the end of the day, provider must be on service at Denver
  • Health for the duration of the study, provider must be willing to avoid wearing white coats

Exclusion Criteria:

  • Refusal to participate
  • Known to be pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537835

Locations
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Angela M Keniston, MSPH       Angela.Keniston@dhha.org   
Principal Investigator: Marisha Burden, MD         
Sponsors and Collaborators
Denver Health and Hospital Authority
University of Colorado, Denver
Investigators
Principal Investigator: Marisha A Burden, MD Denver Health and Housing Authority
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01537835     History of Changes
Other Study ID Numbers: 2-5-15504
Study First Received: February 17, 2012
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
healthcare
worker
uniforms
bacterial
contamination

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014