Focus of Study: HandwashingNCT01583231
Efficacy of the Brushless Scrub
A study testing Prewash in people with Focus of Study: Handwashing, run by Winthrop University Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Handwashing
- What is being tested?
- Prewash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion will consist of all OR personnel and students who scrub for surgical procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Focus of Study: Handwashing
- Being tested
- Prewash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrewashOther
The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.
| Study group | Role | What they receive |
|---|---|---|
| No Prewash | No intervention | Level 1: participants will be swabbed, then application of brushless scrub, swabbed again |
| Prewash | Experimental | Level 2: participants will be swabbed, perform a wash with soap and water for 1 minute, dry, apply brushless scrub, swabbed again Receives: Other: Prewash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bioburden
The procedure of swabbing the participants will be measured by using the RUHOF ATP Complete Contamination Monitoring System.
Measured: 1.5 minutes after brushless scrub was applied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Focus of Study: HandwashingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Criscitelli, Winthrop University Hospital
- Investigators
- Theresa Criscitelli, MS, RN, CNOR, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583231
- Sponsor's protocol ID
- 302192-1
- Status last verified
- Dec 2013
- First submitted
- 21 Feb 2012
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18994678Kampf 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.
PubMed 15489352Hubner 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.
PubMed 16790073Kampf 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.
PubMed 19669812
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Brushless Scrub
- ClinicalTrials.gov ID
- NCT01583231
- Acronym / sponsor ID
- 302192-1
- Conditions
- Focus of Study: Handwashing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Prewash | No intervention | –Level 1: participants will be swabbed, then application of brushless scrub, swabbed again |
| Prewash | Experimental | Other: PrewashLevel 2: participants will be swabbed, perform a wash with soap and water for 1 minute, dry, apply brushless scrub, swabbed again |
Who may qualify
- Ages
- 19 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion will consist of all OR personnel and students who scrub for surgical procedures.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrewashThe intervention will be the addition of the prewash utilizing non-antimicrobial soap and water. | Other | Prewash |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Background: PubMed 18994678Heeg 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.
- Results publication: PubMed 15489352Kampf 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.
- Results publication: PubMed 16790073Hubner 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.
- Results publication: PubMed 19669812Kampf 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Criscitelli, MS, RN, CNOR principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prewash in people with Focus of Study: Handwashing, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bioburden (time frame: 1.5 minutes after brushless scrub was applied). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583231, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.