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Touch and Feel Evaluation of Two Foam Hand Sanitizers

Sponsor
Medline Industries (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05755282
Collaborator
NorthShore University HealthSystem (Other)
45
Enrollment
2
Arms
1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Post-market foam alcohol-based hand sanitizer
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Masking Description:
All participants will try all products. Participants are randomized to the order of study product application.
Primary Purpose:
Other
Official Title:
Touch and Feel Evaluation of Two Foam Hand Sanitizers
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Spectrum Advanced Hand Sanitizer Foam

Half of participants will apply Spectrum Advanced Hand Sanitizer Foam followed by Purell Advanced Hand Sanitizer Foam

Drug: Post-market foam alcohol-based hand sanitizer
Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.
Other Names:
  • Spectrum™ Advanced Hand Sanitizer Foam

    		•
    Other: Purell Advanced Hand Sanitizer Foam

    Half of participants will apply hand Purell Advanced Hand Sanitizer Foam followed by Spectrum Advanced Hand Sanitizer

    Drug: Post-market foam alcohol-based hand sanitizer
    Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.
    Other Names:
  • Spectrum™ Advanced Hand Sanitizer Foam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Objective Foam Sanitizer User Touch and Feel Experience [6 weeks]

      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.

    2. Primary Objective Foam Sanitizer User Preference [6 weeks]

      Healthcare workers' assessment of foam product preference via questionnaire.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medline Industries
    • NorthShore University HealthSystem

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medline Industries
    ClinicalTrials.gov Identifier:
    NCT05755282
    Other Study ID Numbers:
    • MED-2022-DIV60-001
    First Posted:
    Mar 6, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hand Sanitizers

    Study Results

    No Results Posted as of Mar 7, 2023