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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05755282
Other study ID # MED-2022-DIV60-001
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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