Wet Time for a Foam Hand Sanitizer

Hand Hygiene Effectiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05740332
• Other study ID #: MED-2022-DIV60-002
• Status: Completed
• Phase: Phase 4
• Start date: December 12, 2022
• Est. completion date: January 12, 2023

Study information

• Verified date: February 2023
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Hygiene Effectiveness

Intervention

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%)

Locations

Country	Name	City	State
United States	Medline Industries, LP	Northfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

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	Foam Sanitizer Wet Time Duration	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.	4 weeks