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Hand HygieneNCT03445676

Effectiveness of an Alcohol-based Hand Rub to "Clean" Gloved Hands

A study testing ABHR directly on gloves in people with Hand Hygiene, run by University of Maryland, Baltimore at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although little is known about compliance with the World Health Organization (WHO) 5 Moments of hand hygiene, the few existing studies report a high number of opportunities and compliance ranging from just 22 to 60%. 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?
ABHR directly on gloves
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,450 participants
Where
3 sitesUnited States
Study dates
15 Mar 2017to 1 Jan 2019
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 who directly interacts with patients on Contact Precautions

Who cannot join

  • Adults <18 years of age
  • Care for patients with known C. difficile infection
  • No hand hygiene opportunities while at the point of care

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Iowa Hospitals

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Multi-center, Randomized Non-inferiority Trial to Determine if Using Alcohol-based Hand Rub to Clean Gloved Hands When an Indication for HH Arises During a Single Patient Encounter is as Effective as Current Recommendation and Standard Care

Although little is known about compliance with the World Health Organization (WHO) 5 Moments of hand hygiene, the few existing studies report a high number of opportunities and compliance ranging from just 22 to 60%. Previous studies have reported an increased density of opportunities, perceived insufficient time and glove use as factors associated with non-compliance. A healthcare worker performing multiple tasks in one encounter may spend up to half the time in the room doing hand hygiene. Strategies to reduce the time required for hand hygiene may in turn promote increased compliance and may ultimately be most effective in limiting microbial transmission. In this study, the investigators examine whether cleansing gloves at each hand hygiene opportunity at the point of care and reusing the same gloves is as effective as standard practice and the current recommendation (remove gloves, perform hand hygiene, and don new gloves).

Read the detailed description

During this multi-center, randomized non-inferiority trial, eligible healthcare personnel entering rooms of patients on Contact Precautions (or other rooms in which hand hygiene (HH) is an expectation) and who agree to study participation will be randomized to either ideal standard (healthcare worker (HCW) will be directed by study personnel to remove gloves, perform hand hygiene and replace gloves at each HH opportunity), experimental glove-reuse (HCW will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each HH opportunity) or usual care (study personnel silently observe and record what the HCW does at each HH opportunity without direction to the HCW).Care for patients with C. difficile will be excluded as ABHR is not recommended.

This study will be performed at the University of Maryland Medical Center, The R.Adams Cowley Shock Trauma Hospital, University of Iowa Hospitals and The Johns Hopkins Hospital. Healthcare workers on any patient units will be potentially eligible, but the investigators will strive for diversity across unit types (e.g. adult med-surg, general pediatrics, adult ICUs, emergency care areas and inpatient hemodialysis units). The investigators will use a stratified, block randomization scheme to ensure an equal number of participants from each participating unit and facility. The HCW, regardless of random assignment, may choose to remove gloves at any point (e.g. if gloves are heavily soiled or are compromised).

All participants will be instructed on how to perform HH using the standardized WHO methodology and will also receive brief instruction regarding HH opportunities at the point of care using a WHO 5 Moments pamphlet. Participants will don gloves and enter the room to perform patient care activities as planned. Research staff will be in the room to monitor the HCW activity. Research staff trained using the WHO Hand Hygiene Monitoring Method will identify HH opportunities. At each opportunity, the participant will be instructed to stop current activity in the intervention and ideal standard group. Participants in the intervention group will be instructed to cleanse gloves using an ABHR in a standardized way and in a similar fashion to the WHO recommendations for HH. Participants in the ideal standard group will be instructed to remove gloves, perform HH using an ABHR, and don new gloves. The HCW will continue with planned activities and continue to cleanse gloves or perform HH according to study assignment for each opportunity until either the HCW has completed patient care or five HH events have occurred. Study staff will record what the HCW randomized into the usual care arm does at each HH moment. The investigators chose a maximum of five HH events because since most encounters will have five or fewer HH opportunities.

After the final opportunity and after cleansing gloves and allowing them to dry (Intervention Group, glove reuse) after donning new gloves (Ideal Standard) or at moment 5 or before room exit which ever comes first (Usual Care Group) the non-dominant gloved hand will be sampled by directly imprinting the non-dominant gloved hand onto an agar plate. HCWs who have no HH opportunities while at the point of care (e.g. a nurse who enters to the room and interacts only with the intravenous pump and performs HH at exit) will be withdrawn from the study

Conditions
Hand Hygiene
Being tested
ABHR directly on gloves
Keywords
Hand Hygiene, WHO 5-moments

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABHR directly on glovesBehavioural

    HCW will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity

Study groups in NCT03445676
Study groupRoleWhat they receive
Usual CareNo interventionStudy personnel silently observe and record what the healthcare worker does at each hand hygiene opportunity without direction to the healthcare worker
ABHR directly on glovesExperimentalHealthcare worker will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity
Receives: Behavioral: ABHR directly on gloves
Ideal StandardPlacebo comparatorHealthcare worker will be directed by study personnel to remove gloves, perform hand hygiene and replace gloves at each hand hygiene opportunity
Receives: Behavioral: ABHR directly on gloves

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total bacteria colony forming units

    Total bacterial colony forming units cultured from gloved hands will be compared between the intervention and usual care group and between the intervention and ideal standard using a comparison of proportions.

    Measured: Through study completion,about 1 year

Secondary outcomes (1)
  1. Presence of pathogenic organisms

    The presence of pathogenic bacteria on gloved hands in each arm during a single patient encounter

    Measured: Through study completion,about 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start15 Mar 2017
  3. Primary completion1 Jan 2019
  4. Study completion1 Jan 2019

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
1,450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03445676
Sponsor's protocol ID
HP-00065976/69543
Status last verified
May 2020
First submitted
6 Feb 2018
Last updated
7 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thom KA, Rock C, Robinson GL, Reisinger HRS, Baloh J, Chasco E, Liang Y, Li S, Diekema DJ, Herwaldt LA, Johnson JK, Harris AD, Perencevich EN. Alcohol-based decontamination of gloved hands: A randomized controlled trial. Infect Control Hosp Epidemiol. 2024 Apr;45(4):467-473. doi: 10.1017/ice.2023.243. Epub 2023 Nov 23.

    PubMed 37994538

Questions about this trial

What is this clinical trial studying?

A study testing ABHR directly on gloves in people with Hand Hygiene, run by University of Maryland, Baltimore at 3 sites 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 3 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?

Total bacteria colony forming units (time frame: Through study completion,about 1 year). 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 NCT03445676, 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 7 May 2020.

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