Touch and Feel Evaluation of Two Foam Hand Sanitizers

NCT05755282 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MED-2022-DIV60-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Hygiene

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

A: spectrum first then Purell

ACTIVE COMPARATOR

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; Drug: Post-market foam alcohol-based hand sanitizer #2

B: Purell first then spectrum

ACTIVE COMPARATOR

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; Drug: Post-market foam alcohol-based hand sanitizer #2

Interventions

Post-market foam alcohol-based hand sanitizer #1 DRUG

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

Also known as: Spectrum™ Advanced Hand Sanitizer Foam #1

A: spectrum first then Purell; B: Purell first then spectrum

Post-market foam alcohol-based hand sanitizer #2 DRUG

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

Also known as: PURELL® Advanced Foam Hand sanitizer #2

A: spectrum first then Purell; B: Purell first then spectrum

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare workers ≥ 18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related 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 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.

  PMID: 12418624 BACKGROUND

• 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/

  PMID: 23805438 BACKGROUND

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Julie Miller
• Organization: Medline Industries, LP

jamiller@medline.com

630-418-6891

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will try all products. Participants are randomized to the order of study product application.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 6, 2023
• Study Start: April 6, 2023
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)