Hand Hygiene
Conditions
Brief summary
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.
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.
Interventions
DRUGPost-market foam alcohol-based hand sanitizer #1
Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.
DRUGPost-market foam alcohol-based hand sanitizer #2
Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
All participants will try all products. Participants are randomized to the order of study product application.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthcare workers ≥ 18 years of age
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective Foam Sanitizer User Touch and Feel Experience | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
All participants sampled both products (Spectrum and Purell). The order in which they sampled the products was randomized according to a randomization table.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 26 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A: Spectrum First Than Purell | Arm B: Purell First Than Spectrum | Total |
|---|---|---|---|
| Age, Continuous Age by Arm | 42.63 years | 42.00 years | 42.27 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 20 Participants | 35 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 26 | 0 / 26 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 26 | 0 / 26 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 26 | 0 / 26 | 0 / 19 |
Outcome results
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
Time frame: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.
Population: this question was asked after both products had been applied and washed off
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Preference | Purell | 15 Participants |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Preference | Spectrum | 4 Participants |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Preference | Spectrum | 12 Participants |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Preference | Purell | 14 Participants |
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.
Time frame: up to 30 mins to complete on a single day; Directly after both products had been applied and washed off.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Preference 2 | No | 17 Participants |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Preference 2 | Yes | 2 Participants |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Preference 2 | No | 23 Participants |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Preference 2 | Yes | 3 Participants |
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.
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
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | Describe the Sanitizer Quality Ranging from 0 (thin watery) to 100 (thick, foamy) for Spectrum | 53.21 score on a scale | Standard Deviation 19.44 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | Describe the Sanitizer Quality Ranging from 0 (thin watery) to 100 (thick, foamy) for Purell | 61.21 score on a scale | Standard Deviation 26.78 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | Sanitizer spread evenly over hands for full coverage (strongly disagree to strongly agree) Spectrum | 84.58 score on a scale | Standard Deviation 14.87 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | Sanitizer spread evenly over hands for full coverage (strongly disagree to strongly agree) Purell | 82.53 score on a scale | Standard Deviation 16.27 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | After applying, my hands felt hydrated/moisturized strongly disagree to strongly agree Spectrum | 60.05 score on a scale | Standard Deviation 23.28 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | After applying, my hands felt hydrated/moisturized strongly disagree to strongly agree Purell | 60.42 score on a scale | Standard Deviation 20.86 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | Rate the Pleasantness of the Fragrance (strongly disagree to strongly agree) Spectrum | 0.37 score on a scale | Standard Deviation 0.49 |
| Arm A Spectrum Frist Than Purell | Primary Objective Foam Sanitizer User Touch and Feel Experience | Rate the Pleasantness of the Fragrance (strongly disagree to strongly agree) Purell | 0.74 score on a scale | Standard Deviation 0.45 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | Rate the Pleasantness of the Fragrance (strongly disagree to strongly agree) Purell | 0.73 score on a scale | Standard Deviation 0.45 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | Describe the Sanitizer Quality Ranging from 0 (thin watery) to 100 (thick, foamy) for Spectrum | 39.62 score on a scale | Standard Deviation 26.45 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | After applying, my hands felt hydrated/moisturized strongly disagree to strongly agree Spectrum | 60.85 score on a scale | Standard Deviation 22.84 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | Describe the Sanitizer Quality Ranging from 0 (thin watery) to 100 (thick, foamy) for Purell | 49.73 score on a scale | Standard Deviation 23.61 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | Rate the Pleasantness of the Fragrance (strongly disagree to strongly agree) Spectrum | 0.38 score on a scale | Standard Deviation 0.5 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | Sanitizer spread evenly over hands for full coverage (strongly disagree to strongly agree) Spectrum | 73.35 score on a scale | Standard Deviation 22 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | After applying, my hands felt hydrated/moisturized strongly disagree to strongly agree Purell | 68.58 score on a scale | Standard Deviation 19.55 |
| Arm B Purell First Than Spectrum | Primary Objective Foam Sanitizer User Touch and Feel Experience | Sanitizer spread evenly over hands for full coverage (strongly disagree to strongly agree) Purell | 82.38 score on a scale | Standard Deviation 14.34 |