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.

Study Overview

• Status: Completed
• Conditions: Focus of Study: Handwashing
• Intervention / Treatment: Other: Prewash

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Prewash; The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of bioburden	The procedure of swabbing the participants will be measured by using the RUHOF ATP Complete Contamination Monitoring System.	1.5 minutes after brushless scrub was applied

Collaborators and Investigators

• Sponsor: Winthrop University Hospital
• Investigators: Principal Investigator: Theresa Criscitelli, MS, RN, CNOR, Winthrop University Hospital

Publications and helpful links

General Publications

• Heeg P, Ostermeyer C, Kampf G. Comparative review of the test design Tentative Final Monograph (TFM) and EN 12791 for surgical hand disinfectants. J Hosp Infect. 2008 Oct;70 Suppl 1:22-6. doi: 10.1016/S0195-6701(08)60007-9.
• Kampf G, Kramer A. Epidemiologic background of hand hygiene and evaluation of the most important agents for scrubs and rubs. Clin Microbiol Rev. 2004 Oct;17(4):863-93, table of contents. doi: 10.1128/CMR.17.4.863-893.2004.
• Hubner NO, Kampf G, Kamp P, Kohlmann T, Kramer A. Does a preceding hand wash and drying time after surgical hand disinfection influence the efficacy of a propanol-based hand rub? BMC Microbiol. 2006 Jun 22;6:57. doi: 10.1186/1471-2180-6-57.
• Kampf G, Ostermeyer C. A 1-minute hand wash does not impair the efficacy of a propanol-based hand rub in two consecutive surgical hand disinfection procedures. Eur J Clin Microbiol Infect Dis. 2009 Nov;28(11):1357-62. doi: 10.1007/s10096-009-0792-7. Epub 2009 Aug 11.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 23, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 302192-1