Hand Hygiene EffectivenessPhase 4NCT05740332
Wet Time for a Foam Hand Sanitizer
A Phase 4 study testing Alcohol hand sanitizer foam in people with Hand Hygiene Effectiveness, run by Medline Industries at 1 site in United States.
Trial summary
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene Effectiveness
- What is being tested?
- Alcohol hand sanitizer foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 12 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individual ≥ 18 years of age
Who cannot join
- Individual has a self reported skin condition that might result in irritation from the hand sanitizer.
- Individual has a known allergy to the ingredients in the test product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wet Time for a Foam Hand Sanitizer With 70% Ethyl Alcohol
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Spectrum™ Advanced Hand Sanitizer Foam (70%) (hereby referred to as Spectrum Advanced Foam) kills over 99.99% of germs within 15 seconds while boasting double digit increases in hand moisture after two weeks of use.
In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO) published guidance that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply.
This study will evaluate the "wet time" of Spectrum Advanced Foam, which will be defined as the length of time in which the sanitizer foam stays wet on the hands while the participant rubs their hands with the foam sanitizer. The participant will first be asked to wash and dry their hands. Participants will review the appropriate hand sanitizer application steps, as detailed by the WHO guidance. Then, a 1.0 milliliter (mL) aliquot of Spectrum Advanced Foam will be dispensed from an automated dispenser to the participant's hands. The participant will be asked to rub their hands together following the WHO method for hand sanitizer application until they declare the product has dried sufficiently for the donning of medical gloves. Study personnel will measure the wet time of Spectrum Advanced foam using a stopwatch. If the 1.0 ml aliquot does not yield sufficient results to meet WHO guidelines then a 1.4 ml aliquot will be tested, however this was not the case for our study.
Read the detailed description
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. In 2002 and 2009 the CDC and WHO published guidances that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply. The CDC specifically recommends applying alcohol-based hand sanitizers by applying the manufacturer-recommended amount of sanitizer directly to the palm of one hand and then rubbing the hands together. The sanitizer must entirely cover the surfaces of both hands and all fingers while rubbing the hands together until the product has dried. The goal of this study is to evaluate the "wet time" of Spectrum Advanced Foam, which will be defined in this study as the length of time in which the foam sanitizer stays wet on the hands while the participant rubs their hands with the foam sanitizer.
- Conditions
- Hand Hygiene Effectiveness
- Being tested
- Alcohol hand sanitizer foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol hand sanitizer foamDrug
1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.
Other Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | 1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry. Receives: Drug: Alcohol hand sanitizer foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foam Sanitizer Wet Time Duration
To determine the duration of time during which a 1.0 mL aliquot of Spectrum Advanced Hand Sanitizer Foam remains wet under conventional use conditions.
Measured: 2 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start12 Dec 2022
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand Hygiene EffectivenessStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740332
- Sponsor's protocol ID
- MED-2022-DIV60-002
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2023
- Last updated
- 4 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Boyce JM, Pittet D; Healthcare Infection Control Practices Advisory Committee; HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America. MMWR Recomm Rep. 2002 Oct 25;51(RR-16):1-45, quiz CE1-4.
PubMed 12418624WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK144013/
PubMed 23805438
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wet Time for a Foam Hand Sanitizer With 70% Ethyl Alcohol
- ClinicalTrials.gov ID
- NCT05740332
- Acronym / sponsor ID
- MED-2022-DIV60-002
- Conditions
- Hand Hygiene Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Spectrum™ Advanced Hand Sanitizer Foam (70%) (hereby referred to as Spectrum Advanced Foam) kills over 99.99% of germs within 15 seconds while boasting double digit increases in hand moisture after two weeks of use.
In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO) published guidance that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply.
This study will evaluate the "wet time" of Spectrum Advanced Foam, which will be defined as the length of time in which the sanitizer foam stays wet on the hands while the participant rubs their hands with the foam sanitizer. The participant will first be asked to wash and dry their hands. Participants will review the appropriate hand sanitizer application steps, as detailed by the WHO guidance. Then, a 1.0 milliliter (mL) aliquot of Spectrum Advanced Foam will be dispensed from an automated dispenser to the participant's hands. The participant will be asked to rub their hands together following the WHO method for hand sanitizer application until they declare the product has dried sufficiently for the donning of medical gloves. Study personnel will measure the wet time of Spectrum Advanced foam using a stopwatch. If the 1.0 ml aliquot does not yield sufficient results to meet WHO guidelines then a 1.4 ml aliquot will be tested, however this was not the case for our study.
Detailed description
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. In 2002 and 2009 the CDC and WHO published guidances that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply. The CDC specifically recommends applying alcohol-based hand sanitizers by applying the manufacturer-recommended amount of sanitizer directly to the palm of one hand and then rubbing the hands together. The sanitizer must entirely cover the surfaces of both hands and all fingers while rubbing the hands together until the product has dried. The goal of this study is to evaluate the "wet time" of Spectrum Advanced Foam, which will be defined in this study as the length of time in which the foam sanitizer stays wet on the hands while the participant rubs their hands with the foam sanitizer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: Alcohol hand sanitizer foam1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individual ≥ 18 years of age
Key exclusion criteria (2 listed)
- Individual has a self reported skin condition that might result in irritation from the hand sanitizer.
- Individual has a known allergy to the ingredients in the test product.
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 |
|---|---|---|
| Alcohol hand sanitizer foam1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry. Other Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%) | Drug | All participants |
Primary outcome
Foam Sanitizer Wet Time Duration
Time frame: 2 mins
To determine the duration of time during which a 1.0 mL aliquot of Spectrum Advanced Hand Sanitizer Foam remains wet under conventional use conditions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12418624Boyce JM, Pittet D; Healthcare Infection Control Practices Advisory Committee; HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America. MMWR Recomm Rep. 2002 Oct 25;51(RR-16):1-45, quiz CE1-4.
- Results publication: PubMed 23805438WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK144013/
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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 Phase 4 study testing Alcohol hand sanitizer foam in people with Hand Hygiene Effectiveness, run by Medline Industries 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 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 4 Sep 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Foam Sanitizer Wet Time Duration (time frame: 2 mins). 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 NCT05740332, which also lists 2 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 4 Sep 2024; AzTrials last refreshed its copy on 1 Nov 2026.