A Phase 4 interventional study of Alcohol hand sanitizer foam in Hand Hygiene Effectiveness, sponsored by Medline Industries. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Medline Industries · Phase 4, Interventional, and Other
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.
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.
Medline Industries is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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Exclusion Criteria:
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%)
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.
Time frame: 2 mins
| Milestone | All Participants |
|---|---|
| Started | 46 |
| Completed | 46 |
| Not completed | 0 |
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.
| time in seconds | All Participants |
|---|---|
| Foam Sanitizer Wet Time Duration | 35.41 ± 13.51 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 34.6 (23 to 59) |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 30 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2022 to primary completion in Jan 2023, 1 month.
Results were first posted in Sep 2024, 1 year 7 months after primary completion.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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