Hand HygieneNCT01571778
Hand Hygiene Before Non-sterile Glove Use
A study testing Hand Hygiene before Donning Non-sterile Gloves in people with Hand Hygiene, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The importance of healthcare worker hand hygiene in decreasing bacterial transmission between patients is well documented. Healthcare workers may don non-sterile gloves in routine care of patients, particularly for those patients known or suspected to harbor epidemiologically important microorganisms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- Hand Hygiene before Donning Non-sterile Gloves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare worker engaging in direct patient contact on Contact Precautions (e.g. expected glove use)
- >= 18 years of age
Who cannot join
- Visibly soiled hands requiring hand washing (cannot randomize)
- Non-compliance with glove use as indicated for care of patient on Contact Precautions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: The Utility of Hand Hygiene Before Non-sterile Glove Use
The importance of healthcare worker hand hygiene in decreasing bacterial transmission between patients is well documented. Healthcare workers may don non-sterile gloves in routine care of patients, particularly for those patients known or suspected to harbor epidemiologically important microorganisms. Governing bodies currently recommend performing hand hygiene prior to donning gloves and after glove removal. The importance of hand hygiene post glove removal is well shown, however few studies exist to show utility of hand hygiene prior to donning gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce compliance with hand washing. In light of this and the fact that no evidence exists that washing hands BEFORE glove use is important, the aim of the study is to asses the utility of routine hand hygiene prior to donning non-sterile gloves before a patient contact.
- Conditions
- Hand Hygiene
- Being tested
- Hand Hygiene before Donning Non-sterile Gloves
- Keywords
- Hand Hygiene, Non-sterile Glove Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Hygiene before Donning Non-sterile GlovesBehavioural
In the "No Intervention" arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (usual practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens
In the Experimental arm, they will be instructed to don gloves without washing their hands as described.
| Study group | Role | What they receive |
|---|---|---|
| Donning Gloves without Hand Hygiene | Experimental | In this arm, healthcare workers will be assigned to don non-sterile gloves prior to patient contact WITHOUT first performing hand hygiene. Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens Receives: Behavioral: Hand Hygiene before Donning Non-sterile Gloves |
| Hand Hygiene before donning Non-Sterile Gloves | No intervention | In this arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (This is usual,expected practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Total Aerobic Colony Counts
The Difference in Total Aerobic Colony Counts from hands at baseline (Group 1, prior to Hand Hygiene; Group 2, prior to donning gloves) to gloves after donning
Measured: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).
Secondary outcomes (1)
Pathogen Identification
Gloves will be sampled from both groups after donning and evaluation for important hospital pathogens will be performed
Measured: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri A Thom, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571778
- Sponsor's protocol ID
- HP-00051378
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2012
- Last updated
- 18 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Hand Hygiene Before Non-sterile Glove Use
- ClinicalTrials.gov ID
- NCT01571778
- Acronym / sponsor ID
- HP-00051378
- Conditions
- Hand Hygiene
- Keywords
- Hand Hygiene, Non-sterile Glove Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 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 importance of healthcare worker hand hygiene in decreasing bacterial transmission between patients is well documented. Healthcare workers may don non-sterile gloves in routine care of patients, particularly for those patients known or suspected to harbor epidemiologically important microorganisms. Governing bodies currently recommend performing hand hygiene prior to donning gloves and after glove removal. The importance of hand hygiene post glove removal is well shown, however few studies exist to show utility of hand hygiene prior to donning gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce compliance with hand washing. In light of this and the fact that no evidence exists that washing hands BEFORE glove use is important, the aim of the study is to asses the utility of routine hand hygiene prior to donning non-sterile gloves before a patient contact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donning Gloves without Hand Hygiene | Experimental | Behavioral: Hand Hygiene before Donning Non-sterile GlovesIn this arm, healthcare workers will be assigned to don non-sterile gloves prior to patient contact WITHOUT first performing hand hygiene. Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens |
| Hand Hygiene before donning Non-Sterile Gloves | No intervention | –In this arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (This is usual,expected practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare worker engaging in direct patient contact on Contact Precautions (e.g. expected glove use)
- >= 18 years of age
Key exclusion criteria (2 listed)
- Visibly soiled hands requiring hand washing (cannot randomize)
- Non-compliance with glove use as indicated for care of patient on Contact Precautions
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 |
|---|---|---|
| Hand Hygiene before Donning Non-sterile GlovesIn the "No Intervention" arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (usual practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens In the Experimental arm, they will be instructed to don gloves without washing their hands as described. | Behavioural | Donning Gloves without Hand Hygiene |
Primary outcome
Difference in Total Aerobic Colony Counts
Time frame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).
The Difference in Total Aerobic Colony Counts from hands at baseline (Group 1, prior to Hand Hygiene; Group 2, prior to donning gloves) to gloves after donning
1 secondary outcome
Pathogen Identification
Time frame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).
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 18 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Hygiene before Donning Non-sterile Gloves in people with Hand Hygiene, run by University of Maryland, Baltimore 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 2 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 18 Mar 2022. 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?
Difference in Total Aerobic Colony Counts (time frame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2022; AzTrials last refreshed its copy on 4 Nov 2026.