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Trial record 1 of 10359 for:    Anti-Infective Agents AND Bacterial
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Bacterial Contamination of Healthcare Worker Uniforms

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ClinicalTrials.gov Identifier: NCT01537835
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Bacterial Contamination of Healthcare Worker Uniforms
Intervention Other: Antimicrobial Scrubs
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Hide Arm/Group Description 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.

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.

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.

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.

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.

Period Title: Overall Study
Started 37 37 35
Completed 37 37 35
Not Completed 0 0 0
Arm/Group Title Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2 Total
Hide Arm/Group Description 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.

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 35 35 35 105
Hide Baseline Analysis Population Description
Please note two participants in the standard scrub group and two participants in the antimicrobial scrub group A were excluded from analysis.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Not Available Number Analyzed 35 participants 35 participants 35 participants 105 participants
NA [2]  NA [2]  NA [2]  NA [3] 
[1]
Measure Description: Age was not collected.
[2]
Age was not collected
[3]
Total not calculated because data are not available (NA) in one or more arms.
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Not Available Number Analyzed 35 participants 35 participants 35 participants 105 participants
NA [2]  NA [2]  NA [2]  NA [3] 
[1]
Measure Description: Gender was not collected.
[2]
Gender was not collected
[3]
Total not calculated because data are not available (NA) in one or more arms.
healthcare worker type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 105 participants
attending physician 5 3 3 11
intern/resident 17 16 18 51
midlevels 2 2 2 6
nurse 11 14 12 37
cared for colonized or infected patient  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 105 participants
16 20 19 55
1.Primary Outcome
Title Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.
Hide Description 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.
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
healthcare workers randomized to one of three types of uniform.
Arm/Group Title Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Hide Arm/Group Description:
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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 35 35 35
Median (Inter-Quartile Range)
Unit of Measure: colony formation units
41
(20 to 70)
65
(35 to 117)
41
(22 to 99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Scrubs, Antimicrobial Scrubs 1, Antimicrobial Scrubs 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments p-value is adjusted for multiple comparisons
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Healthcare workers randomized to one of three types of uniform
Arm/Group Title Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Hide Arm/Group Description:
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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 35 35 35
Measure Type: Number
Unit of Measure: participants
0 1 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Hide Arm/Group Description 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.

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.

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.

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.

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.

All-Cause Mortality
Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Scrubs Antimicrobial Scrubs 1 Antimicrobial Scrubs 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marisha Burden, MD
Organization: Denver Health and Hospital Authority
Phone: 303-602-5011
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