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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-market foam alcohol-based hand sanitizer #1 | Drug | Automated dispenser will dispense 1 mL of hand sanitizer product onto hands. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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" | 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. | up to 30 mins to complete on a single day; Directly after both products had been applied and washed off. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12418624 | Background | 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. | |
| 23805438 |
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All participants sampled both products (Spectrum and Purell). The order in which they sampled the products was randomized according to a randomization table.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Spectrum First Than Purell | Arm A participants first applied spectrum hand sanitizer followed by a washout period. They then applied Purell hand sanitizer. |
| FG001 | Arm B: Purell First Than Spectrum | Arm B participants first applied purell hand sanitizer followed by a washout period. They then applied spectrum hand sanitizer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants were randomized using a randomization table to either Arm A or Arm B
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Spectrum First Than Purell | Arm A participants first applied spectrum hand sanitizer followed by a washout period. They then applied Purell hand sanitizer. |
| BG001 | Arm B: Purell First Than Spectrum |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | participants were asked to report their age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | up to 30 mins to complete on a single day; Directly after participants hands have dried after application of each hand sanitizer product |
|
Adverse events were collected for the study duration of 30 mins
No adverse events of any level were noted. These products were already being used regularly by these healthcare professionals in the facility.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Spectrum First Then Purell While Using Spectrum | Arm A applied spectrum hand sanitizer first, followed by a washout period, then applied purell hand sanitizer. These results report adverse events for group A while using spectrum |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Miller | Medline Industries, LP | 630-418-6891 | jamiller@medline.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2022 | Aug 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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All participants will try all products. Participants are randomized to the order of study product application.
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| Post-market foam alcohol-based hand sanitizer #2 | Drug | Automated dispenser will dispense 1 mL of hand sanitizer product onto hands. |
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| Background |
| 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/ |
Arm B participants first applied Purell hand sanitizer followed by a washout period. They then applied Spectrum hand sanitizer.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | Arm B Purell First Than Spectrum | Arm B participants first applied purell hand sanitizer followed by a washout period, then applied spectrum hand sanitizer. |
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| Primary | 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" | this question was asked after both products had been applied and washed off | Posted | Count of Participants | Participants | up to 30 mins to complete on a single day; Directly after both products had been applied and washed off. |
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | up to 30 mins to complete on a single day; Directly after both products had been applied and washed off. |
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| 0 |
| 19 |
| 0 |
| 19 |
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| 19 |
| EG001 | Arm B: Purell First Then Spectrum While Using Purell | Arm B applied Purell hand sanitizer first, followed by a washout period, then applied spectrum hand sanitizer These results report adverse events for group B while usuing Purell | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Arm B: Purell First Then Spectrum While Using Spectrum | Arm B applied Purell hand sanitizer first, followed by a washout period, then applied spectrum hand sanitizer These results report adverse events for group B while using Spectrum | 0 | 26 | 0 | 26 | 0 | 26 |
| EG003 | Arm A Applied Spectrum Hand Sanitizer Firs Then Purell While Using Purell | Arm A applied spectrum hand sanitizer first, followed by a washout period, then applied purell hand sanitizer. These results report adverse events for group A while using Purell | 0 | 19 | 0 | 19 | 0 | 19 |
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