Wet Time for a Foam Hand Sanitizer

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

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) 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. If the 1.0 ml aliquot does not yield sufficient results to meet WHO guidelines then a 1.4 ml aliquot will be tested, however this was not the case for our study.

Study Overview

• Status: Completed
• Conditions: Hand Hygiene Effectiveness
• Intervention / Treatment: Drug: Alcohol hand sanitizer foam

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Northfield, Illinois, United States, 60093
      • Medline Industries, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foam Sanitizer Wet Time Duration	To determine the duration of time during which a 1.0 mL aliquot of Spectrum Advanced Hand Sanitizer Foam remains wet under conventional use conditions.	2 mins

Collaborators and Investigators

• Sponsor: Medline Industries

Publications and helpful links

General Publications

• 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.
• 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/

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Hand Sanitizers
• Other Study ID Numbers: MED-2022-DIV60-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes