Efficacy of the Brushless Scrub

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583231
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
Theresa Criscitelli, Winthrop University Hospital

February 21, 2012
April 23, 2012
December 19, 2013
May 2012
April 2013   (Final data collection date for primary outcome measure)
Reduction of bioburden [ Time Frame: 1.5 minutes after brushless scrub was applied ]
The procedure of swabbing the participants will be measured by using the RUHOF ATP Complete Contamination Monitoring System.
Same as current
Complete list of historical versions of study NCT01583231 on Archive Site
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Efficacy of the Brushless Scrub
Efficacy of the Brushless Scrub

The aim of this research is to examine if the brushless scrub is effective in reducing bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction between both methods.

Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases bioburden than brushless scrub alone.

Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the application of the brushless scrub within 20 seconds of application for both groups.

Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes after application of the brushless scrub for both groups.

Hand washing by operating room personnel prior to surgical procedures is essential in the prevention of intraoperative infection. The use of the brushless surgical hand hygiene has been used since the CDC stated in 2002 that using a brush and sponge is no longer necessary. Empirical literature supports the reduction of the incidence of bacteria or OR personnel hands with the use of alcohol-based products.

An annotated integrative search of the literature was conducted and conflicting information regarding the use of a prewash prior to the brushless scrub was found. This study can help us utilize the brushless scrub to the fullest capacity and prevent surgical site infections.

The time point at which the outcome measure will be assessed at an individual level will be immediately pre-intervention and also 1.5 minutes after the intervention. For example, within 15 seconds prior to brushless scrub, or prewash, a sample swab will be collected and then another sample swab will be obtained 1.5 minutes later for postintervention measure. The study should take approximately 4 months to complete to get an adequate sample size of individuals for statistical power. The data will be aggregated and presented at a staff in-service within 3 months after data collection and analysis is completed.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Focus of Study: Handwashing
Other: Prewash
The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.
  • No Intervention: No Prewash
    Level 1: participants will be swabbed, then application of brushless scrub, swabbed again
  • Experimental: Prewash
    Level 2: participants will be swabbed, perform a wash with soap and water for 1 minute, dry, apply brushless scrub, swabbed again
    Intervention: Other: Prewash

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion will consist of all OR personnel and students who scrub for surgical procedures.

Exclusion Criteria:

  • Exclusion will consist of any OR personnel and students whom do not want to participate in the study or those who have not been part of the the routine and mandatory training of proper surgical hand hygiene which occurs annually.
Sexes Eligible for Study: All
19 Years to 62 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Theresa Criscitelli, Winthrop University Hospital
Winthrop University Hospital
Not Provided
Principal Investigator: Theresa Criscitelli, MS, RN, CNOR Winthrop University Hospital
Winthrop University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP