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Completed

NCT Number: NCT05740332

Wet Time for a Foam Hand Sanitizer

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medline Industries, LP

Northfield, Illinois, 60093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alcohol hand sanitizer foam

Drug

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%)

Primary outcomes

  1. Foam Sanitizer Wet Time Duration

    Time frame: 2 mins

    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.

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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