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Trial record 1 of 1 for:    The Antiseptic Scrub Contamination and Transmission (ASCOT) Trial
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Antiseptic Scrub Contamination and Transmission Trial (ASCOT)

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ClinicalTrials.gov Identifier: NCT02645214
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study is a prospective, blinded, randomized, controlled trial (RCT) with a crossover design to determine if antiseptic-impregnated surgical scrubs decrease the burden of healthcare providers (HCP) clothing contamination compared to standard, control surgical scrubs following a 12-hour ICU shift.

Condition or disease Intervention/treatment Phase
Disease Transmission Other: Non-antiseptic scrubs Other: Antiseptic scrubs Not Applicable

Detailed Description:

The investigators will perform a 3-arm prospective, blinded, randomized, controlled trial with a cross-over design to determine if HCP who wear antiseptic-impregnated clothing (i.e., surgical scrubs) will acquire and transmit fewer pathogens than HCP wearing standard clothing.

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Antiseptic Scrub Contamination and Transmission Trial: A Randomized Controlled Trial to Evaluate the Impact of Antiseptic Scrubs on Bacterial Contamination.
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Placebo Comparator: Control scrubs (non-antiseptic)
subject will wear control scrubs for the duration of a 12-hour ICU shift
Other: Non-antiseptic scrubs
Active Comparator: Antiseptic Impregnated Scrubs Type 1
subject will wear antiseptic impregnated scrubs-type 1 for the duration of a 12-hour ICU shift
Other: Antiseptic scrubs
Active Comparator: Antiseptic Impregnated Scrubs Type 2
subject will wear antiseptic impregnated scrubs-type 2 for the duration of a 12-hour ICU shift
Other: Antiseptic scrubs



Primary Outcome Measures :
  1. The difference in total acquired contamination (Total CFU) on HCP clothing at the end of a 12-hour ICU shift. [ Time Frame: At the end of a 12-hour ICU shift ]

Secondary Outcome Measures :
  1. The presence or absence of individual specific pathogens: S. aureus (MRSA or MSSA), Enterococci (VRE or VSE), Acinetobacter spp., Pseudomonas spp., and Enterobacteriaceae of interest such as E. coli and Klebsiella spp. [ Time Frame: At the end of a 12-hour ICU shift ]
  2. The proportion of positive cultures - overall and at each culture location [ Time Frame: At the end of three 12-hour ICU shifts ]
  3. The number of suspected and confirmed "transmission events" [ Time Frame: At the end of three 12-hour ICU shifts ]
  4. The proportion of suspected and confirmed "transmission events" [ Time Frame: At the end of three 12-hour ICU shifts ]
  5. Health care personnel perceptions of clothing as measured by survey [ Time Frame: At the end of a 12-hour ICU shift ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All intensive care unit (ICU) nurses at Duke Medical Center are eligible to participate in this study.

Exclusion Criteria:

  • Nurses outside the Duke Medical Center ICU will not be eligible to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645214


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Deverick Anderson, MD, MPH Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02645214    
Other Study ID Numbers: Pro00062781
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.
Additional relevant MeSH terms:
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Anti-Infective Agents, Local
Anti-Infective Agents