Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT02984527
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2016-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Traditional Bed Baths Versus Disposable Wet Wipes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microbiological counts on skin before and after interventions', 'timeFrame': 'two consecutive days', 'description': 'microbiological counts from skin swaps before and after washing with water and soap and before and after washing with disposable wipes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intimate Hygiene']}, 'descriptionModule': {'briefSummary': 'The Purpose of the study is to compare the effectiveness on microbiological counts from skin swaps after wash with water and soap or wet wipes.', 'detailedDescription': 'The study is a crossover clinical trial where the effect of two interventions is compared on the same subject.\n\nThe two interventions are:\n\n* Intimate hygiene with water and soap\n* Intimate hygiene with prepackaged disposable wet wipes\n\nNull hypothesis: Same effectiveness to reduce microbiological counts on skin\n\nAlternative hypothesis: Significant different effectiveness to reduce microbiological counts on skin\n\nEach individual receives the two interventions in random order. The effect of the interventions on microbiological counts on the patients skin is evaluated on the same patient.\n\nA crossover trial requires half the number of participants and reduces confounding factors.\n\nAll participants receive a sequence of the two different interventions. But there is a sufficient gab between the two interventions to ensure a washout period and avoid a crossover effect. In this study this is 12-24 hours.\n\nThe study uses block randomization, without intra block correlation to achieve allocation balance over time.\n\nFurthermore it may prevent some predictable allocation.\n\nMicrobiological sampling with moistened swaps and aseptic techniques, sterile equipment and sterile recovery medium (Stewarts Medium) are used to obtain skin samples from the patients before and after intimate hygiene with water and soap and wet wipes.\n\nDifferences in microbiological skin counts will be compared (delta values) before and after the two interventions and between interventions.\n\nData will be blinded during microbiological count and statistical analyses.\n\nAnalyses:\n\nData are structured in CASTOR and will be stored in a secure Team Collaboration Software Tool (SharePoint).\n\nDescriptive analysis including mean, median, confidence interval, standard deviation, and standard error.\n\nStatistical analyses will be performed using STATA. Test of differences will be performed by simple t- test or Wilcoxon sign rank test, depending on the distribution of the data. A multiple regression analysis including possible confounders will be considered.\n\nInclusion of 68 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who need intimate hygiene\n* Admitted for minimum two days\n* Understand oral information\n* And apple to sign written consent\n\nExclusion Criteria:\n\n* Diarrhea\n* Dementia\n* Dying'}, 'identificationModule': {'nctId': 'NCT02984527', 'briefTitle': 'Traditional Bed Baths Versus Disposable Wet Wipes', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Comparison of Skin Swaps From Traditional Bed Baths Versus Disposable Wet Wipes', 'orgStudyIdInfo': {'id': 'SDUSF-2015-65/R1 - (205)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'water and soap first day', 'description': 'Intimate hygiene performed with water and soap first day and disposable wet wipes second day', 'interventionNames': ['Device: wet wipes', 'Device: water and soap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'disposable wet wipes first day', 'description': 'Intimate hygiene performed with wet wipes first day and water and soap second day', 'interventionNames': ['Device: wet wipes', 'Device: water and soap']}], 'interventions': [{'name': 'wet wipes', 'type': 'DEVICE', 'description': 'intimate hygiene with disposable wet wipes', 'armGroupLabels': ['disposable wet wipes first day', 'water and soap first day']}, {'name': 'water and soap', 'type': 'DEVICE', 'description': 'Intimate hygiene with water and soap', 'armGroupLabels': ['disposable wet wipes first day', 'water and soap first day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Aabenraa', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'Hospital of Southern Jutland', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}], 'overallOfficials': [{'name': 'Jette Primdahl, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital of Southern Jutland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital of Southern Jutland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Pia Lysdal Veje', 'investigatorAffiliation': 'University of Southern Denmark'}}}}