Antiseptic Scrub Contamination and Transmission Trial (ASCOT)

February 13, 2017 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At the end of a 12-hour ICU shift

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At the end of a 12-hour ICU shift
The proportion of positive cultures - overall and at each culture location
Time Frame: At the end of three 12-hour ICU shifts
At the end of three 12-hour ICU shifts
The number of suspected and confirmed "transmission events"
Time Frame: At the end of three 12-hour ICU shifts
At the end of three 12-hour ICU shifts
The proportion of suspected and confirmed "transmission events"
Time Frame: At the end of three 12-hour ICU shifts
At the end of three 12-hour ICU shifts
Health care personnel perceptions of clothing as measured by survey
Time Frame: At the end of a 12-hour ICU shift
At the end of a 12-hour ICU shift

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Deverick Anderson, MD, MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 31, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00062781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

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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