Antiseptic Scrub Contamination and Transmission Trial (ASCOT)

Duke University

Status: Completed

Conditions: Disease Transmission

Treatments: Other: Antiseptic scrubs; Other: Non-antiseptic scrubs

Study type: Interventional

Funder types: Other

Identifiers

NCT02645214

Pro00062781

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 3 patient groups, including a placebo group

Control scrubs (non-antiseptic)

Placebo Comparator group

Description:

subject will wear control scrubs for the duration of a 12-hour ICU shift

Treatment:

Other: Non-antiseptic scrubs

Antiseptic Impregnated Scrubs Type 1

Active Comparator group

Description:

subject will wear antiseptic impregnated scrubs-type 1 for the duration of a 12-hour ICU shift

Treatment:

Other: Antiseptic scrubs

Antiseptic Impregnated Scrubs Type 2

Active Comparator group

Description:

subject will wear antiseptic impregnated scrubs-type 2 for the duration of a 12-hour ICU shift

Treatment:

Other: Antiseptic scrubs