Hand HygieneSHoRTNCT02396836
Randomised Controlled Trial (RCT) of 6 Versus 3 Steps for Hand Hygiene
A study testing 6 step technique and 3 step technique in people with Hand Hygiene, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
The aim is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand rub technique in hand coverage and in reducing bacterial contamination on the hands of healthcare workers in practice. Research questions 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- 6 step technique and 3 step technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical and nursing staff performing a clinical procedure
Who cannot join
- A procedure requiring use of gloves
- A self declared active skin condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of the Effectiveness of Two Hand Hygiene Techniques Using Alcohol Based Hand Rub on Hand Surface Coverage and Reducing Bacterial Hand Contamination
The aim is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand rub technique in hand coverage and in reducing bacterial contamination on the hands of healthcare workers in practice.
Research questions
- What is the effectiveness of the 6 step technique in hand coverage compared to the 3 step technique?
- What are the most frequently missed sites in hand surface coverage using 6 steps compared to 3 steps?
- What is the reduction in bacterial contamination of the hand with the 6 step compared to the 3 step technique?
- Does site missed or coverage relate to bacterial load?
- What is the time taken for 6 step technique versus 3 step technique?
Read the detailed description
The 6 step for decontamination of healthcare workers hand is recommended by the World Health Organization but the 3 step technique is easy to perform and has been shown by some studies to be effective. Compliance with the 6 step technique is not optimum. If the 3 step was more as or more effective than the 6 step compliance with it could be compared with that for the 6 step. No randomised controlled trial comparing the effectiveness of these two techniques using alcohol based hand rub has been conducted.
- Conditions
- Hand Hygiene
- Being tested
- 6 step technique, 3 step technique
- Keywords
- Hand hygiene, Hand decontamination, Microbial load, Hand coverage, Glove juice technique, Ayliffe technique, 6 step technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 step techniqueOther
Also called World Health Organisation 6 step technique for hand hygiene
Hand decontamination with alcohol hand rub using the World Health Organizations 6 step technique
3 step techniqueOther
Also called 3 step technique for hand hygiene
Hand decontamination with alcohol hand rub using the 3 step technique
| Study group | Role | What they receive |
|---|---|---|
| 6 step hand hygiene technique | Active comparator | Hand decontamination with alcohol hand rub using the World Health Organisations 6 step technique Receives: Other: 6 step technique |
| 3 step hand hygiene technique | Experimental | Hand decontamination with alcohol hand rub using the 3 step technique Receives: Other: 3 step technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial load on dominant hand
A glove juice technique will be used to assess the microbial load on the dominant hand of healthcare workers following use of alcohol hand rub after a clinical procedure.
Measured: up to 5 min
Secondary outcomes (1)
Hand coverage
Ultra violet box will be used to assess hand coverage of the hands of healthcare workers following use of alcohol hand rub.
Measured: up to 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Strathclyde, University of East Anglia, NHS Greater Glasgow and Clyde, Tan Tock Seng Hospital
- Responsible party
- Principal investigator, Jacqui Reilly, Glasgow Caledonian University
- Investigators
- Jacqui Reilly, PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396836
- Sponsor's protocol ID
- 12-170
- Other IDs
- SIRN04
- Acronym
- SHoRT
- Status last verified
- Mar 2015
- First submitted
- 15 Aug 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reilly JS, Price L, Lang S, Robertson C, Cheater F, Skinner K, Chow A. A Pragmatic Randomized Controlled Trial of 6-Step vs 3-Step Hand Hygiene Technique in Acute Hospital Care in the United Kingdom. Infect Control Hosp Epidemiol. 2016 Jun;37(6):661-6. doi: 10.1017/ice.2016.51. Epub 2016 Apr 7.
PubMed 27050843
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Effectiveness of Two Hand Hygiene Techniques Using Alcohol Based Hand Rub on Hand Surface Coverage and Reducing Bacterial Hand Contamination
- ClinicalTrials.gov ID
- NCT02396836
- Acronym / sponsor ID
- SHoRT / 12-170
- Conditions
- Hand Hygiene
- Keywords
- Hand hygiene, Hand decontamination, Microbial load, Hand coverage, Glove juice technique, Ayliffe technique, 6 step technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- University of Strathclyde, University of East Anglia, NHS Greater Glasgow and Clyde, Tan Tock Seng Hospital
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Mar 2015 (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 is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand rub technique in hand coverage and in reducing bacterial contamination on the hands of healthcare workers in practice.
Research questions
- What is the effectiveness of the 6 step technique in hand coverage compared to the 3 step technique?
- What are the most frequently missed sites in hand surface coverage using 6 steps compared to 3 steps?
- What is the reduction in bacterial contamination of the hand with the 6 step compared to the 3 step technique?
- Does site missed or coverage relate to bacterial load?
- What is the time taken for 6 step technique versus 3 step technique?
Detailed description
The 6 step for decontamination of healthcare workers hand is recommended by the World Health Organization but the 3 step technique is easy to perform and has been shown by some studies to be effective. Compliance with the 6 step technique is not optimum. If the 3 step was more as or more effective than the 6 step compliance with it could be compared with that for the 6 step. No randomised controlled trial comparing the effectiveness of these two techniques using alcohol based hand rub has been conducted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 step hand hygiene technique | Active comparator | Other: 6 step techniqueHand decontamination with alcohol hand rub using the World Health Organisations 6 step technique |
| 3 step hand hygiene technique | Experimental | Other: 3 step techniqueHand decontamination with alcohol hand rub using the 3 step technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical and nursing staff performing a clinical procedure
Key exclusion criteria (2 listed)
- A procedure requiring use of gloves
- A self declared active skin condition
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 |
|---|---|---|
| 6 step techniqueAlso: World Health Organisation 6 step technique for hand hygieneHand decontamination with alcohol hand rub using the World Health Organizations 6 step technique | Other | 6 step hand hygiene technique |
| 3 step techniqueAlso: 3 step technique for hand hygieneHand decontamination with alcohol hand rub using the 3 step technique | Other | 3 step hand hygiene technique |
Primary outcome
Microbial load on dominant hand
Time frame: up to 5 min
A glove juice technique will be used to assess the microbial load on the dominant hand of healthcare workers following use of alcohol hand rub after a clinical procedure.
1 secondary outcome
Hand coverage
Time frame: up to 5 min
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 24 Mar 2015.
- Derived from this study: PubMed 27050843Reilly JS, Price L, Lang S, Robertson C, Cheater F, Skinner K, Chow A. A Pragmatic Randomized Controlled Trial of 6-Step vs 3-Step Hand Hygiene Technique in Acute Hospital Care in the United Kingdom. Infect Control Hosp Epidemiol. 2016 Jun;37(6):661-6. doi: 10.1017/ice.2016.51. Epub 2016 Apr 7.
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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.
Jacqui Reilly, PhD principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 step technique and 3 step technique in people with Hand Hygiene, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 2 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 24 Mar 2015. 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 Kingdom. 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?
Microbial load on dominant hand (time frame: up to 5 min). 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 NCT02396836, which also lists 1 linked publication.
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 24 Mar 2015.