Bacterial Contamination of Healthcare Worker Uniforms
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday. [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. [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 2-5-15504
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 |
|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 | Total |
|---|---|---|---|---|
| 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 Participants | 35 | 35 | 35 | 105 |
| Age, Customized (participants) [Number] | ||||
| Not Available |
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Sex/Gender, Customized (participants) [Number] | ||||
| Not Available |
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| healthcare worker type (participants) [Number] | ||||
| attending physician |
5
14.3%
|
3
8.6%
|
3
8.6%
|
11
10.5%
|
| intern/resident |
17
48.6%
|
16
45.7%
|
18
51.4%
|
51
48.6%
|
| midlevels |
2
5.7%
|
2
5.7%
|
2
5.7%
|
6
5.7%
|
| nurse |
11
31.4%
|
14
40%
|
12
34.3%
|
37
35.2%
|
| cared for colonized or infected patient (participants) [Number] | ||||
| Number [participants] |
16
45.7%
|
20
57.1%
|
19
54.3%
|
55
52.4%
|
Outcome Measures
| Title | Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| healthcare workers randomized to one of three types of uniform. |
| Arm/Group Title | Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 |
|---|---|---|---|
| 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. |
| Measure Participants | 35 | 35 | 35 |
| Median (Inter-Quartile Range) [colony formation units] |
41
|
65
|
41
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard Scrubs, Antimicrobial Scrubs 1, Antimicrobial Scrubs 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | p-value is adjusted for multiple comparisons | |
| Method | Kruskal-Wallis | |
| Comments | ||
| 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. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Healthcare workers randomized to one of three types of uniform |
| Arm/Group Title | Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 |
|---|---|---|---|
| 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. |
| Measure Participants | 35 | 35 | 35 |
| Number [participants] |
0
0%
|
1
2.9%
|
2
5.7%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Standard Scrubs | Antimicrobial Scrubs 1 | Antimicrobial Scrubs 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) | |||
Limitations/Caveats
More Information
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 |
| Marisha.Burden@dhha.org |
- 2-5-15504