Trial Outcomes & Findings for Bacterial Contamination of Healthcare Worker Uniforms (NCT NCT01537835)
NCT ID: NCT01537835
Last Updated: 2015-02-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
8 hours
Results posted on
2015-02-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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.
|
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.
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 Study
STARTED
|
37
|
37
|
35
|
|
Overall Study
COMPLETED
|
37
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bacterial Contamination of Healthcare Worker Uniforms
Baseline characteristics by cohort
| Measure |
Standard Scrubs
n=35 Participants
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.
|
Antimicrobial Scrubs 1
n=35 Participants
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.
|
Antimicrobial Scrubs 2
n=35 Participants
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
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Not Available
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
NA participants
n=4 Participants
|
|
Sex/Gender, Customized
Not Available
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
NA participants
n=4 Participants
|
|
healthcare worker type
attending physician
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
healthcare worker type
intern/resident
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
healthcare worker type
midlevels
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
healthcare worker type
nurse
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
cared for colonized or infected patient
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
55 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: healthcare workers randomized to one of three types of uniform.
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.
Outcome measures
| Measure |
Standard Scrubs
n=35 Participants
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.
|
Antimicrobial Scrubs 1
n=35 Participants
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.
|
Antimicrobial Scrubs 2
n=35 Participants
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 Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.
|
41 colony formation units
Interval 20.0 to 70.0
|
65 colony formation units
Interval 35.0 to 117.0
|
41 colony formation units
Interval 22.0 to 99.0
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: Healthcare workers randomized to one of three types of uniform
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.
Outcome measures
| Measure |
Standard Scrubs
n=35 Participants
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.
|
Antimicrobial Scrubs 1
n=35 Participants
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.
|
Antimicrobial Scrubs 2
n=35 Participants
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.
|
|---|---|---|---|
|
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.
|
0 participants
|
1 participants
|
2 participants
|
Adverse Events
Standard Scrubs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antimicrobial Scrubs 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antimicrobial Scrubs 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marisha Burden, MD
Denver Health and Hospital Authority
Phone: 303-602-5011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place