- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594580
Contamination of Hospital Scrubs
A Novel Agent to Decrease Contamination of Hospital Scrubs
This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will:
- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering
This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The outcome of interest is the contamination of scrubs with Staphylococcus aureus, Enterococcus species or Gram-negative bacteria as determined by surface swabs of healthcare worker scrubs after a full 8-hour shift. The outcomes will be analyzed both individually and collectively.
Contamination will be defined as:
- A swab that is determined to be positive for any Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nursing staff engaging in direct patient care
- Working in select/participating intensive care and intermediate care units
- Working at least 8 day shifts in one month (study period)
Exclusion Criteria:
- Pregnant
- Unable to provide consent
- Unable to follow study schedule
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Antimicrobial impregnated scrubs
Those randomized to this arm of the study will wear scrubs impregnated with an antimicrobial.
|
Scrubs are impregnated with an antimicrobial product
|
|
Placebo Comparator: Non-impregnated scrubs
Those randomized to this arm of the study will wear scrubs not impregnated with an antimicrobial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bacterial contamination of scrubs
Time Frame: Outcome will be assessed at the end of the hospital shift ( approx 8 hours)
|
Contamination will be defined as:
|
Outcome will be assessed at the end of the hospital shift ( approx 8 hours)
|
Collaborators and Investigators
Investigators
- Principal Investigator: J Kristie Johnson, PhD, University of Maryland School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00051506
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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