Touch and Feel Evaluation of Two Foam Hand Sanitizers

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.

Study Overview

• Status: Completed
• Conditions: Hand Hygiene
• Intervention / Treatment: Drug: Post-market foam alcohol-based hand sanitizer #1; Drug: Post-market foam alcohol-based hand sanitizer #2

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A: spectrum first then Purell; Half of participants will apply Spectrum Advanced (#1) Hand Sanitizer Foam followed by Purell Advanced (#2) Hand Sanitizer Foam	Drug: Post-market foam alcohol-based hand sanitizer #1; Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.; Other Names: Spectrum™ Advanced Hand Sanitizer Foam #1; Drug: Post-market foam alcohol-based hand sanitizer #2; Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.; Other Names: PURELL® Advanced Foam Hand sanitizer #2
Active Comparator: B: Purell first then spectrum; Half of participants will apply hand Purell Advanced (#2) Hand Sanitizer Foam followed by Spectrum Advanced (#1) Hand Sanitizer	Drug: Post-market foam alcohol-based hand sanitizer #1; Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.; Other Names: Spectrum™ Advanced Hand Sanitizer Foam #1; Drug: Post-market foam alcohol-based hand sanitizer #2; Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.; Other Names: PURELL® Advanced Foam Hand sanitizer #2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Medline Industries
• Collaborators: NorthShore University HealthSystem

Publications and helpful links

General Publications

• 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/
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Disinfectants; Ethanol; Hand Sanitizers
• Other Study ID Numbers: MED-2022-DIV60-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes