Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-06-30
2016-01-31
Brief Summary
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Detailed Description
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A total of 40 intensive care unit (ICU) nurses (from the Medical and Surgical ICUs in the Duke Medical Pavilion) will be enrolled and sign a consent form to participate in the study. Their main task will be to wear control (non- antiseptic) scrubs (Arm 1) and two different types of antiseptic-impregnated scrubs (Arms 2 and 3). Subjects will be randomized to one of 6 strategies. Each nurse typically cares for two patients each day and will be enrolled for three consecutive days (or shifts, if they do not work for 3 days in a row). Once the nurses have consented to participate in this project, the study coordinator will provide the 3 sets of scrubs and will label them with numbers, thus blinding the nurses to which scrubs they will wear on which day. The nurse will wear the scrubs on the 3 pre-arranged shifts.
Data will be summarized using standard statistical methods. The investigators will utilize linear mixed models to compare relative differences in the amount of contamination between arms at the end of the shift to adjust for our crossover study design. Mixed effects logistic regression models will be used to compare proportions. All calculations will be adjusted for the amount of environmental contamination observed during the shift and contamination on HCP clothing in the beginning of the shift. Statistical significance for two primary comparisons (each antiseptic scrub versus control) will be corrected for multiple comparisons.
This is a minimal risk study and the investigators have no safety concerns from the patients or nurses as relates to obtaining swabs and room cultures, nor with wearing the scrubs and having them cultured. Data will be stored on encrypted Duke Medicine servers (participant log \& study IDs) and/or in our REDCap database (all other data collected for the study).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Control scrubs (non-antiseptic)
subject will wear control scrubs for the duration of a 12-hour ICU shift
Non-antiseptic scrubs
Antiseptic Impregnated Scrubs Type 1
subject will wear antiseptic impregnated scrubs-type 1 for the duration of a 12-hour ICU shift
Antiseptic scrubs
Antiseptic Impregnated Scrubs Type 2
subject will wear antiseptic impregnated scrubs-type 2 for the duration of a 12-hour ICU shift
Antiseptic scrubs
Interventions
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Non-antiseptic scrubs
Antiseptic scrubs
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Deverick Anderson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Anderson DJ, Addison R, Lokhnygina Y, Warren B, Sharma-Kuinkel B, Rojas LJ, Rudin SD, Lewis SS, Moehring RW, Weber DJ, Rutala WA, Bonomo RA, Fowler VG, Sexton DJ; CDC Prevention Epicenters Program. The Antimicrobial Scrub Contamination and Transmission (ASCOT) Trial: A Three-Arm, Blinded, Randomized Controlled Trial With Crossover Design to Determine the Efficacy of Antimicrobial-Impregnated Scrubs in Preventing Healthcare Provider Contamination. Infect Control Hosp Epidemiol. 2017 Oct;38(10):1147-1154. doi: 10.1017/ice.2017.181. Epub 2017 Aug 29.
Other Identifiers
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Pro00062781
Identifier Type: -
Identifier Source: org_study_id
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