Wet Time for a Foam Hand Sanitizer

NCT05740332 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MED-2022-DIV60-002
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Hand Hygiene Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All participants

EXPERIMENTAL

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

Drug: Alcohol hand sanitizer foam

Interventions

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%)

All participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual ≥ 18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Medline Industries, LP

Northfield, Illinois, 60093, United States

Location

Related 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 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.

  PMID: 12418624 RESULT

• 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/

  PMID: 23805438 RESULT

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Director Clinical Operations
• Organization: Medline Industries LP

jamiller@medline.com

630-418-6891

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: December 12, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Locations

US (1)