Wet Time for a Foam Hand Sanitizer

Sponsor

Medline Industries (Industry)

Overall Status

Completed

CT.gov ID

NCT05740332

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

45.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Spectrum™ Advanced Hand Sanitizer Foam (70%) (hereby referred to as Spectrum Advanced Foam) kills over 99.99% of germs within 15 seconds while boasting double digit increases in hand moisture after two weeks of use.

In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO) published guidance that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply.

This study will evaluate the "wet time" of Spectrum Advanced Foam, which will be defined as the length of time in which the sanitizer foam stays wet on the hands while the participant rubs their hands with the foam sanitizer. The participant will first be asked to wash and dry their hands. Participants will review the appropriate hand sanitizer application steps, as detailed by the WHO guidance. Then, a 1.0 milliliter (mL) or 1.4 mL aliquot of Spectrum Advanced Foam will be dispensed from an automated dispenser to the participant's hands. The participant will be asked to rub their hands together following the WHO method for hand sanitizer application until they declare the product has dried sufficiently for the donning of medical gloves. Study personnel will measure the wet time of Spectrum Advanced foam using a stopwatch.

Condition or Disease	Intervention/Treatment	Phase
Hand Hygiene Effectiveness	Drug: Alcohol hand sanitizer foam	Phase 4

Detailed Description

Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. In 2002 and 2009 the CDC and WHO published guidances that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply. The CDC specifically recommends applying alcohol-based hand sanitizers by applying the manufacturer-recommended amount of sanitizer directly to the palm of one hand and then rubbing the hands together. The sanitizer must entirely cover the surfaces of both hands and all fingers while rubbing the hands together until the product has dried. The goal of this study is to evaluate the "wet time" of Spectrum Advanced Foam, which will be defined in this study as the length of time in which the foam sanitizer stays wet on the hands while the participant rubs their hands with the foam sanitizer.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Wet Time for a Foam Hand Sanitizer With 70% Ethyl Alcohol

Actual Study Start Date :

Dec 12, 2022

Actual Primary Completion Date :

Jan 12, 2023

Actual Study Completion Date :

Jan 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All participants 1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.	Drug: Alcohol hand sanitizer foam 1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry. Other Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)

Arm

Intervention/Treatment

Experimental: All participants

1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.

Drug: Alcohol hand sanitizer foam

1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry. Other Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)

Outcome Measures

Primary Outcome Measures

Foam Sanitizer Wet Time Duration [4 weeks]
To determine the duration of time during which a 1.0 mL or 1.4 mL* aliquot of Spectrum Advanced Hand Sanitizer Foam remains wet under conventional use conditions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Individual ≥ 18 years of age

Exclusion Criteria:

Individual has a self reported skin condition that might result in irritation from the hand sanitizer.
Individual has a known allergy to the ingredients in the test product.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medline Industries, LP	Northfield	Illinois	United States	60093

Sponsors and Collaborators

Medline Industries

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medline Industries

ClinicalTrials.gov Identifier:

NCT05740332

Other Study ID Numbers:

MED-2022-DIV60-002

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Hand Sanitizers

Study Results

No Results Posted as of Feb 24, 2023