Hand HygienePhase 4NCT05755282

Touch and Feel Evaluation of Two Foam Hand Sanitizers

A Phase 4 study testing Post-market foam alcohol-based hand sanitizer #1 and Post-market foam alcohol-based hand sanitizer #2 in people with Hand Hygiene, run by Medline Industries at 1 site 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

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Hand Hygiene
What is being tested?: Post-market foam alcohol-based hand sanitizer #1 and Post-market foam alcohol-based hand sanitizer #2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 6 Apr 2023to 12 Apr 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

Healthcare workers ≥ 18 years of age

Who cannot join

Individual has a skin condition that might result in irritation from the hand sanitizers.
Individual has a known allergy to the ingredients in the test products.

Trial locations and contacts

1 site in 1 country.

United States1 site

NorthShore University HealthSystem
Evanston, Illinois, 60201

Other trials in United States

About this study

Hand sanitizers are a standard of hygiene requirements. Hand sanitizers must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. To improve compliance with hand sanitizing protocols, hand sanitizers should provide a pleasant touch and feel experience for end users, especially for healthcare worker (HCW) users, who use these products frequently.

Read the detailed description

Hand sanitizers are a standard of hygiene requirements. Hand sanitizers are a standard tool frequently used in hospital settings by healthcare (HCWs) for hand disinfection. The Centers for Disease Control and Prevention (CDC) states that HCWs should use an alcohol-based hand rub, such as a hand sanitizer, or wash their hands with soap and water immediately before and after patient contact, during aseptic tasks, after contact with blood, bodily fluids, or contaminated surfaces, and immediately after glove removal. 1 Additionally, the World Health Organization (WHO) guidelines on hand hygiene state that alcohol-based handrubs rapidly and effectively inactivate a wide array of potentially harmful microorganisms on hands. 2 Hand sanitizers must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. To improve compliance with hand sanitizing protocols, hand sanitizers should provide a pleasant touch and feel experience for users, especially for healthcare worker (HCW) users.

The goal of this study is to evaluate the user touch and feel experience of two hand sanitizer foam products produced by Medline and GOJO when the products are used by HCWs.

Conditions: Hand Hygiene
Being tested: Post-market foam alcohol-based hand sanitizer #1, Post-market foam alcohol-based hand sanitizer #2

What participants receive

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

Post-market foam alcohol-based hand sanitizer #1Drug
Also called Spectrum™ Advanced Hand Sanitizer Foam #1
Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.
Post-market foam alcohol-based hand sanitizer #2Drug
Also called PURELL® Advanced Foam Hand sanitizer #2
Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Study groups in NCT05755282
Study group	Role	What they receive
A: spectrum first then Purell	Active comparator	Half of participants will apply Spectrum Advanced (#1) Hand Sanitizer Foam followed by Purell Advanced (#2) Hand Sanitizer Foam Receives: Drug: Post-market foam alcohol-based hand sanitizer #1; Drug: Post-market foam alcohol-based hand sanitizer #2
B: Purell first then spectrum	Active comparator	Half of participants will apply hand Purell Advanced (#2) Hand Sanitizer Foam followed by Spectrum Advanced (#1) Hand Sanitizer Receives: Drug: Post-market foam alcohol-based hand sanitizer #1; Drug: Post-market foam alcohol-based hand sanitizer #2

What is being measured

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

Primary Objective Foam Sanitizer User Touch and Feel Experience
The user touch and feel experience of the foam hand sanitizer products evaluated by visual analog scale assessments (VAS) ranging from 0 to 100, with higher scores indicating a more favorable outcome, of healthcare workers overall satisfaction and moisturization.
Measured: up to 30 mins to complete on a single day; Directly after participants hands have dried after application of each hand sanitizer product
Primary Objective Foam Sanitizer User Preference
Healthcare workers' assessment of foam product preference via questionnaire, this was asked "and this question was asked after both *products* had been applied and washed off"
Measured: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.
Primary Objective Foam Sanitizer User Preference 2
Participants were asked "If the other product was chosen by the facility, I would object". this was asked in the time window after both products had already been applied and washed off and therefore this question has a different arms grouping than the first set of questions. It was not asked when a given product was on the skin. The participants were blinded to the product being tested at a given time -- so there was no intent to connect this question to the product testing. The facility had clearly labeled wall units with hand sanitizer and all nurses were aware of what brand of product hand sanitizer the facility used.
Measured: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.

Timeline

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

6 Apr 202312 Apr 2023

First posted6 Mar 2023
Study start6 Apr 2023
Primary completion12 Apr 2023
Study completion12 Apr 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 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05755282
Sponsor's protocol ID: MED-2022-DIV60-001
Status last verified: Jul 2024
First submitted: 3 Feb 2023
Last updated: 1 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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 12418624
WHO 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Touch and Feel Evaluation of Two Foam Hand Sanitizers
ClinicalTrials.gov ID: NCT05755282
Acronym / sponsor ID: MED-2022-DIV60-001
Conditions: Hand Hygiene
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Study start: 6 Apr 2023 (actual)
Primary completion: 12 Apr 2023 (actual)
Study completion: 12 Apr 2023 (actual)
First posted: 6 Mar 2023 (actual)
Results: Posted 1 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The goal of this study is to evaluate the user touch and feel experience of two hand sanitizer foam products produced by Medline and GOJO when the products are used by HCWs.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
A: spectrum first then Purell	Active comparator	Drug: Post-market foam alcohol-based hand sanitizer #1, Drug: Post-market foam alcohol-based hand sanitizer #2Half of participants will apply Spectrum Advanced (#1) Hand Sanitizer Foam followed by Purell Advanced (#2) Hand Sanitizer Foam
B: Purell first then spectrum	Active comparator	Drug: Post-market foam alcohol-based hand sanitizer #1, Drug: Post-market foam alcohol-based hand sanitizer #2Half of participants will apply hand Purell Advanced (#2) Hand Sanitizer Foam followed by Spectrum Advanced (#1) Hand Sanitizer

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthcare workers ≥ 18 years of age

Key exclusion criteria (2 listed)

Individual has a skin condition that might result in irritation from the hand sanitizers.
Individual has a known allergy to the ingredients in the test products.

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
Post-market foam alcohol-based hand sanitizer #1Also: Spectrum™ Advanced Hand Sanitizer Foam #1Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.	Drug	A: spectrum first then Purell, B: Purell first then spectrum
Post-market foam alcohol-based hand sanitizer #2Also: PURELL® Advanced Foam Hand sanitizer #2Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.	Drug	A: spectrum first then Purell, B: Purell first then spectrum

Primary outcome

Primary Objective Foam Sanitizer User Touch and Feel Experience
Time frame: up to 30 mins to complete on a single day; Directly after participants hands have dried after application of each hand sanitizer product
The user touch and feel experience of the foam hand sanitizer products evaluated by visual analog scale assessments (VAS) ranging from 0 to 100, with higher scores indicating a more favorable outcome, of healthcare workers overall satisfaction and moisturization.
Primary Objective Foam Sanitizer User Preference
Time frame: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.
Healthcare workers' assessment of foam product preference via questionnaire, this was asked "and this question was asked after both *products* had been applied and washed off"
Primary Objective Foam Sanitizer User Preference 2
Time frame: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.
Participants were asked "If the other product was chosen by the facility, I would object". this was asked in the time window after both products had already been applied and washed off and therefore this question has a different arms grouping than the first set of questions. It was not asked when a given product was on the skin. The participants were blinded to the product being tested at a given time -- so there was no intent to connect this question to the product testing. The facility had clearly labeled wall units with hand sanitizer and all nurses were aware of what brand of product hand sanitizer the facility used.

Results and safety

Results posted to the registry on 1 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Spectrum First Than Purell	19	19
Arm B: Purell First Than Spectrum	27	26

Primary outcome: Primary Objective Foam Sanitizer User Touch and Feel Experience

Time frame: up to 30 mins to complete on a single day; Directly after participants hands have dried after application of each hand sanitizer product. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm A Spectrum Frist Than Purell n = 19	Arm B Purell First Than Spectrum n = 26
"Describe the Sanitizer Quality" Ranging from 0 (thin watery) to 100 (thick, foamy) for Spectrum	53.21 (19.44)	39.62 (26.45)
"Describe the Sanitizer Quality" Ranging from 0 (thin watery) to 100 (thick, foamy) for Purell	61.21 (26.78)	49.73 (23.61)
Sanitizer spread evenly over hands for full coverage (strongly disagree to strongly agree) Spectrum	84.58 (14.87)	73.35 (22.00)
Sanitizer spread evenly over hands for full coverage (strongly disagree to strongly agree) Purell	82.53 (16.27)	82.38 (14.34)
After applying, my hands felt hydrated/moisturized strongly disagree to strongly agree Spectrum	60.05 (23.28)	60.85 (22.84)
After applying, my hands felt hydrated/moisturized strongly disagree to strongly agree Purell	60.42 (20.86)	68.58 (19.55)
Rate the Pleasantness of the Fragrance" (strongly disagree to strongly agree) Spectrum	0.37 (0.49)	0.38 (0.50)
Rate the Pleasantness of the Fragrance" (strongly disagree to strongly agree) Purell	0.74 (0.45)	0.73 (0.45)

Population analysed: Participants were asked to answer four questions about each of the products and then asked which product they preferred (see preference outcome measure documented separately)

Primary outcome: Primary Objective Foam Sanitizer User Preference

Time frame: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.. Count of participants. Unit: Participants

Measure	Arm A: Spectrum First Then Purell n = 19	Arm B: Purell First Then Spectrum n = 26
Spectrum	4	12
Purell	15	14

Population analysed: this question was asked after both products had been applied and washed off

Primary outcome: Primary Objective Foam Sanitizer User Preference 2

Time frame: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.. Count of participants. Unit: Participants

Measure	Arm A: Spectrum First Then Purell n = 19	Arm B: Purell First Than Spectrum n = 26
No	17	23
Yes	2	3

Population analysed: Both Arm participants answered the survey question if they would object if their facility switched hand sanitzers from the current product being used at their facility (yes or no). this was asked in the time window after both products had already been applied and washed off and therefore this question has a different arms grouping than the first set of questions. It was not asked when a given product was on the skin.

Adverse events

Time frame: Adverse events were collected for the study duration of 30 mins. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Spectrum First Then Purell While Using Spectrum	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Arm B: Purell First Then Spectrum While Using Purell	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Arm B: Purell First Then Spectrum While Using Spectrum	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Arm A Applied Spectrum Hand Sanitizer Firs Then Purell While Using Purell	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: 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.
Background: 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/
Individual participant dataSharing planned: No

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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?

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 1 Aug 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 1 Aug 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?

Primary Objective Foam Sanitizer User Touch and Feel Experience (time frame: up to 30 mins to complete on a single day; Directly after participants hands have dried after application of each hand sanitizer product). The study lists 3 primary outcomes in all. 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 NCT05755282, 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 1 Aug 2024.