Touch and Feel Evaluation of Two Foam Hand Sanitizers

Hand Hygiene Clinical Trial

Official title:

Touch and Feel Evaluation of Two Foam Hand Sanitizers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755282
• Other study ID #: MED-2022-DIV60-001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 6, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: Medline Industries
• Contact: Christine E Richards, BS
• Phone: 6303918399
• Email: crichards[@]medline.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: May 31, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Hygiene

Intervention

Drug:
• Post-market foam alcohol-based hand sanitizer
Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medline Industries	NorthShore University HealthSystem

References & Publications (2)

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 Commit — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks
Primary	Primary Objective Foam Sanitizer User Preference	Healthcare workers' assessment of foam product preference via questionnaire.	6 weeks