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Efficacy of the Brushless Scrub

NCT ID: NCT01583231

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Focus of Study: Handwashing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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No Prewash

Level 1: participants will be swabbed, then application of brushless scrub, swabbed again

Group Type NO_INTERVENTION

No interventions assigned to this group

Prewash

Level 2: participants will be swabbed, perform a wash with soap and water for 1 minute, dry, apply brushless scrub, swabbed again

Group Type EXPERIMENTAL

Prewash

Intervention Type OTHER

The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.

Interventions

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Prewash

The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Winthrop University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Theresa Criscitelli

Director of Perioperative Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa Criscitelli, MS, RN, CNOR

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

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Winthrop University Hospital

Mineola, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18994678 (View on PubMed)

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.

Reference Type RESULT
PMID: 15489352 (View on PubMed)

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.

Reference Type RESULT
PMID: 16790073 (View on PubMed)

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.

Reference Type RESULT
PMID: 19669812 (View on PubMed)

Other Identifiers

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302192-1

Identifier Type: -

Identifier Source: org_study_id