Bacterial Contamination of Healthcare Worker Uniforms

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01537835

First Posted: February 23, 2012

Last Update Posted: February 23, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University of Colorado, Denver

Information provided by (Responsible Party):

Denver Health and Hospital Authority

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 Intervention Model: Parallel Assignment Masking: None (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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

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

Primary Outcome Measures:

Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday. [ Time Frame: 8 hours ]
Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.

Secondary Outcome Measures:

Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform. [ Time Frame: 8 hours ]
Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.


Enrollment:	109
Study Start Date:	November 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537835

Locations


United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204

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:

Burden M, Cervantes L, Weed D, Keniston A, Price CS, Albert RK. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized controlled trial. J Hosp Med. 2011 Apr;6(4):177-82. doi: 10.1002/jhm.864. Epub 2011 Feb 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Burden M, Keniston A, Frank MG, Brown CA, Zoucha J, Cervantes L, Weed D, Boyle K, Price C, Albert RK. Bacterial contamination of healthcare workers' uniforms: a randomized controlled trial of antimicrobial scrubs. J Hosp Med. 2013 Jul;8(7):380-5. doi: 10.1002/jhm.2051. Epub 2013 Jun 12.


Responsible Party:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT01537835 History of Changes
Other Study ID Numbers:	2-5-15504
First Submitted:	February 17, 2012
First Posted:	February 23, 2012
Results First Submitted:	December 17, 2014
Results First Posted:	February 23, 2015
Last Update Posted:	February 23, 2015
Last Verified:	February 2015

Keywords provided by Denver Health and Hospital Authority:


healthcare worker uniforms bacterial contamination

Additional relevant MeSH terms:


Anti-Infective Agents Anti-Bacterial Agents

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