Touch and Feel Evaluation of Two Foam Hand Sanitizers

Studies

Study First Submitted Date	2023-02-03
Study First Posted Date	2023-03-06
Last Update Posted Date	2023-03-29
Start Month Year	April 6, 2023
Primary Completion Month Year	May 15, 2023
Verification Month Year	February 2023
Verification Date	2023-02-28
Last Update Posted Date	2023-03-29

Detailed Descriptions

Sequence:

20731686

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.

Browse Interventions

Sequence:	96096451	Sequence:	96096452	Sequence:	96096453	Sequence:	96096454
Mesh Term	Hand Sanitizers	Mesh Term	Anti-Infective Agents, Local	Mesh Term	Anti-Infective Agents	Mesh Term	Disinfectants
Downcase Mesh Term	hand sanitizers	Downcase Mesh Term	anti-infective agents, local	Downcase Mesh Term	anti-infective agents	Downcase Mesh Term	disinfectants
Mesh Type	mesh-list	Mesh Type	mesh-ancestor	Mesh Type	mesh-ancestor	Mesh Type	mesh-ancestor

Conditions

Sequence:	52197465
Name	Hand Hygiene
Downcase Name	hand hygiene

Id Information

Sequence:	40178464
Id Source	org_study_id
Id Value	MED-2022-DIV60-001

Design Groups

Sequence:	55623209	Sequence:	55623210
Group Type	Other	Group Type	Other
Title	Spectrum Advanced Hand Sanitizer Foam	Title	Purell Advanced Hand Sanitizer Foam
Description	Half of participants will apply Spectrum Advanced Hand Sanitizer Foam followed by Purell Advanced Hand Sanitizer Foam	Description	Half of participants will apply hand Purell Advanced Hand Sanitizer Foam followed by Spectrum Advanced Hand Sanitizer

Interventions

Sequence:	52512206
Intervention Type	Drug
Name	Post-market foam alcohol-based hand sanitizer
Description	Automated dispenser will dispense 1 mL of hand sanitizer product onto hands.

Design Outcomes

Sequence:	177476326	Sequence:	177476327
Outcome Type	primary	Outcome Type	primary
Measure	Primary Objective Foam Sanitizer User Touch and Feel Experience	Measure	Primary Objective Foam Sanitizer User Preference
Time Frame	6 weeks	Time Frame	6 weeks
Description	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.	Description	Healthcare workers' assessment of foam product preference via questionnaire.

Central Contacts

Sequence:	12014907
Contact Type	primary
Name	Christine E Richards, BS
Phone	6303918399
Email	[email protected]
Role	Contact

Design Group Interventions

Sequence:	68185913	Sequence:	68185914
Design Group Id	55623210	Design Group Id	55623209
Intervention Id	52512206	Intervention Id	52512206

Eligibilities

Sequence:	30780694
Gender	All
Minimum Age	18 Years
Maximum Age	99 Years
Healthy Volunteers	Accepts Healthy Volunteers
Criteria	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.
Adult	True
Child	False
Older Adult	True

Calculated Values

Sequence:	253976190
Registered In Calendar Year	2023
Were Results Reported	False
Has Single Facility	False
Minimum Age Num	18
Maximum Age Num	99
Minimum Age Unit	Years
Maximum Age Unit	Years
Number Of Primary Outcomes To Measure	2

Designs

Sequence:	30526789
Allocation	Randomized
Intervention Model	Crossover Assignment
Observational Model
Primary Purpose	Other
Time Perspective
Masking	Single
Masking Description	All participants will try all products. Participants are randomized to the order of study product application.
Subject Masked	True

Intervention Other Names

Sequence:	26687277
Intervention Id	52512206
Name	Spectrum™ Advanced Hand Sanitizer Foam

Responsible Parties

Sequence:	28893095
Responsible Party Type	Sponsor

Study References

Sequence:	52090653	Sequence:	52090654
Pmid	12418624	Pmid	23805438
Reference Type	result	Reference Type	result
Citation	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.	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/

Sequence:	48343540	Sequence:	48343541
Agency Class	INDUSTRY	Agency Class	OTHER
Lead Or Collaborator	lead	Lead Or Collaborator	collaborator
Name	Medline Industries	Name	NorthShore University HealthSystem