Touch and Feel Evaluation of Two Foam Hand Sanitizers

NCT ID: NCT05755282

Last Updated: 2024-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2023-04-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hand Hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
All participants will try all products. Participants are randomized to the order of study product application.

Study Groups

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A: spectrum first then Purell

Half of participants will apply Spectrum Advanced (#1) Hand Sanitizer Foam followed by Purell Advanced (#2) Hand Sanitizer Foam

Group Type ACTIVE_COMPARATOR

Post-market foam alcohol-based hand sanitizer #1

Intervention Type DRUG

Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Post-market foam alcohol-based hand sanitizer #2

Intervention Type DRUG

Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

B: Purell first then spectrum

Half of participants will apply hand Purell Advanced (#2) Hand Sanitizer Foam followed by Spectrum Advanced (#1) Hand Sanitizer

Group Type ACTIVE_COMPARATOR

Post-market foam alcohol-based hand sanitizer #1

Intervention Type DRUG

Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Post-market foam alcohol-based hand sanitizer #2

Intervention Type DRUG

Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Interventions

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Post-market foam alcohol-based hand sanitizer #1

Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Intervention Type DRUG

Post-market foam alcohol-based hand sanitizer #2

Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Intervention Type DRUG

Other Intervention Names

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Spectrum™ Advanced Hand Sanitizer Foam #1 PURELL® Advanced Foam Hand sanitizer #2

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12418624 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 23805438 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MED-2022-DIV60-001

Identifier Type: -

Identifier Source: org_study_id

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