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Completed

NCT Number: NCT02645214

Antiseptic Scrub Contamination and Transmission Trial

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.

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Key information

Conditions

Disease Transmission

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-antiseptic scrubs

Other

Antiseptic scrubs

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Antiseptic Scrub Contamination and Transmission Trial: A Randomized Controlled Trial to Evaluate the Impact of Antiseptic Scrubs on Bacterial Contamination.

Acronym: ASCOT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2016
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.