Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT06194903
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average total bacterial load at 3 hours after sanitization', 'timeFrame': 'Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation.', 'description': 'The primary objective of the pilot study is to obtain preliminary data on the average total bacterial load at 3 hours after the sanitization intervention (70% isopropyl alcohol wipes or UVC box). These data will allow appropriate sizing of a subsequent trial to evaluate whether, on the cell phones of health care workers at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS, wipes impregnated with 70% isopropyl alcohol are more effective than UVC ray boxes in reducing total bacterial load at 3 hours after sanitization for both isopropyl alcohol wipes and UVC box'}], 'secondaryOutcomes': [{'measure': 'Change in the average total bacterial load at 3 hours after sanitization', 'timeFrame': 'Samples will be collected immediately before and immediately after sanitisation and 3 hours after sanitisation', 'description': 'Explore the change in the average total bacterial load at 3 hours after sanitization interventions compared with the value recorded before sanitisation for both isopropyl alcohol wipes and UVC box.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cross infection', 'high touch surfaces', 'cellphone', 'disinfection', 'isopropyl alcohol', 'UVC'], 'conditions': ['Cross Infection']}, 'descriptionModule': {'briefSummary': 'Cell phones have become a fundamental accessory of our lives and clinical practice, often kept in contact with the body. Since most modern smartphones are equipped with touch screens, they can serve the function of reservoirs for pathogenic microorganisms; moreover, they can be the means of transmission of such microorganisms from the environment to humans.\n\nA number of observational studies are available in the literature evaluating the effectiveness of various sanitization methods in reducing the bacterial load of high-touch devices, both chemical and physical.\n\nTo our knowledge, no real-world evidence is available comparing the residual effect of the two methods on the bacterial load of cell phones, since all available studies are carried out in the laboratory, with inoculums of predetermined bacterial loads whose suppression by the disinfectant is monitored over time, and involve laptops, tablets and keyboards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a healthcare provider in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS\n* Own a smartphone\n* Carry one\'s smartphone for the duration of the work shift (8 hours)\n* Give consent to participate in the study\n* Be willing to report 3 hours after sanitisation for follow-up sampling\n\nExclusion Criteria:\n\n* Not to be a healthcare worker in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS\n* Not to be on work shift during surveys\n* Not to carry one\'s smartphone for the duration of the work shift (8 hours)\n* Not to give consent to participate in the study\n* Not to be willing to report 3 hours after sanitisation for follow-up sampling'}, 'identificationModule': {'nctId': 'NCT06194903', 'acronym': 'SaniPhone', 'briefTitle': 'Randomized Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Randomized Experimental Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones of Healthcare Workers.', 'orgStudyIdInfo': {'id': '6015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cellphones treated with isopropyl alcohol wipes', 'interventionNames': ['Device: isopropyl alcohol wipes']}, {'type': 'EXPERIMENTAL', 'label': 'Cellphones treated with UVC box', 'interventionNames': ['Device: UVC box']}], 'interventions': [{'name': 'isopropyl alcohol wipes', 'type': 'DEVICE', 'description': 'cellphones will be sanitised with isopropyl alcohol wipes and total bacterial load will be assessed immediately before sanitation, immediately after sanitation and 3 hours after sanitation.', 'armGroupLabels': ['Cellphones treated with isopropyl alcohol wipes']}, {'name': 'UVC box', 'type': 'DEVICE', 'description': 'cellphones will be sanitised in a UVC box and total bacterial load will be assessed immediately before sanitation, immediately after sanitation and 3 hours after sanitation.', 'armGroupLabels': ['Cellphones treated with UVC box']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario "A. Gemelli" IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Laurenti Patrizia', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}