Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT05740332
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Wet Time for a Foam Hand Sanitizer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamiller@medline.com', 'phone': '630-418-6891', 'title': 'Director Clinical Operations', 'organization': 'Medline Industries LP'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': '1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nAlcohol hand sanitizer foam: 1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nOther Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Foam Sanitizer Wet Time Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': '1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nAlcohol hand sanitizer foam: 1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nOther Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)'}], 'classes': [{'categories': [{'measurements': [{'value': '35.41', 'spread': '13.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 mins', 'description': '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.', 'unitOfMeasure': 'time in seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '46 healthy adult participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': '1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nAlcohol hand sanitizer foam: 1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nOther Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': '1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nAlcohol hand sanitizer foam: 1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nOther Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '59'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-18', 'size': 1644929, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-11T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2023-02-13', 'resultsFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-09', 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foam Sanitizer Wet Time Duration', 'timeFrame': '2 mins', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Hygiene Effectiveness']}, 'referencesModule': {'references': [{'pmid': '12418624', 'type': 'RESULT', 'citation': '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': '23805438', 'type': 'RESULT', '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/'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThis 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual ≥ 18 years of age\n\nExclusion Criteria:\n\n* Individual has a self reported skin condition that might result in irritation from the hand sanitizer.\n* Individual has a known allergy to the ingredients in the test product.'}, 'identificationModule': {'nctId': 'NCT05740332', 'briefTitle': 'Wet Time for a Foam Hand Sanitizer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'Wet Time for a Foam Hand Sanitizer With 70% Ethyl Alcohol', 'orgStudyIdInfo': {'id': 'MED-2022-DIV60-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants', 'description': '1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.', 'interventionNames': ['Drug: Alcohol hand sanitizer foam']}], 'interventions': [{'name': 'Alcohol hand sanitizer foam', 'type': 'DRUG', 'description': '1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.\n\nOther Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60093', 'city': 'Northfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Medline Industries, LP', 'geoPoint': {'lat': 42.09975, 'lon': -87.7809}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}