Trial Outcomes & Findings for Touch and Feel Evaluation of Two Foam Hand Sanitizers (NCT NCT05755282)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

up to 30 mins to complete on a single day; Directly after participants hands have dried after application of each hand sanitizer product

Results posted on

2024-08-01

Participant Flow

All participants sampled both products (Spectrum and Purell). The order in which they sampled the products was randomized according to a randomization table.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	27
Overall Study COMPLETED	19	26
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Spectrum First Than Purell n=19 Participants Arm A participants first applied spectrum hand sanitizer followed by a washout period. They then applied Purell hand sanitizer.	Arm B: Purell First Than Spectrum n=26 Participants Arm B participants first applied Purell hand sanitizer followed by a washout period. They then applied Spectrum hand sanitizer.	Total n=45 Participants Total of all reporting groups
Age, Continuous Age by Arm	42.63 years n=19 Participants	42.00 years n=26 Participants	42.27 years n=45 Participants
Sex: Female, Male Female	15 Participants n=19 Participants	20 Participants n=26 Participants	35 Participants n=45 Participants
Sex: Female, Male Male	4 Participants n=19 Participants	6 Participants n=26 Participants	10 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Arm A Spectrum Frist Than Purell n=19 Participants Arm A participants first applied spectrum hand sanitizer followed by a washout period, then applied purell hand sanitizer.	Arm B Purell First Than Spectrum n=26 Participants Arm B participants first applied purell hand sanitizer followed by a washout period, then applied spectrum hand sanitizer.
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	39.62 score on a scale Standard Deviation 26.45
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	49.73 score on a scale Standard Deviation 23.61
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	73.35 score on a scale Standard Deviation 22.00
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	82.38 score on a scale Standard Deviation 14.34
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	60.85 score on a scale Standard Deviation 22.84
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	68.58 score on a scale Standard Deviation 19.55
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	0.38 score on a scale Standard Deviation 0.50
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	0.73 score on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: 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

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"

Outcome measures

Outcome measures
Measure	Arm A Spectrum Frist Than Purell n=19 Participants Arm A participants first applied spectrum hand sanitizer followed by a washout period, then applied purell hand sanitizer.	Arm B Purell First Than Spectrum n=26 Participants Arm B participants first applied purell hand sanitizer followed by a washout period, then applied spectrum hand sanitizer.
Primary Objective Foam Sanitizer User Preference Spectrum	4 Participants	12 Participants
Primary Objective Foam Sanitizer User Preference Purell	15 Participants	14 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A Spectrum Frist Than Purell n=19 Participants Arm A participants first applied spectrum hand sanitizer followed by a washout period, then applied purell hand sanitizer.	Arm B Purell First Than Spectrum n=26 Participants Arm B participants first applied purell hand sanitizer followed by a washout period, then applied spectrum hand sanitizer.
Primary Objective Foam Sanitizer User Preference 2 No	17 Participants	23 Participants
Primary Objective Foam Sanitizer User Preference 2 Yes	2 Participants	3 Participants

Adverse Events

Arm A: Spectrum First Then Purell While Using Spectrum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B: Purell First Then Spectrum While Using Purell

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B: Purell First Then Spectrum While Using Spectrum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm A Applied Spectrum Hand Sanitizer Firs Then Purell While Using Purell

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Miller

Medline Industries, LP

Phone: 630-418-6891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60