Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05347927
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2022-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Skin microbiome swabs are collected for micribiome analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'products´ influence on skin microbiome during fracture management', 'timeFrame': '3 weeks', 'description': 'Quantity of bacteria in the skin microbiome'}, {'measure': 'products´ influence on skin microbiome during fracture management', 'timeFrame': '3 weeks', 'description': 'Taxonomic composition of skin microbiome'}, {'measure': 'products´ influence on skin microbiome during fracture management', 'timeFrame': '3 weeks', 'description': 'Alpha diversity of skin microbiome'}, {'measure': 'products´ influence on skin microbiome during fracture management', 'timeFrame': '3 weeks', 'description': 'Beta diversity skin microbiome'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events during study per product', 'timeFrame': '3 weeks'}, {'measure': 'General product performance', 'timeFrame': '3 weeks'}, {'measure': 'Treatment comfort', 'timeFrame': '3 weeks'}, {'measure': 'Impact on daily life activities', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Microbiome', 'Undercast Materials']}, 'descriptionModule': {'briefSummary': 'This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with broken forwarm receiving short arm cast', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject ≥ 18 years of age\n2. Patient is physically and mentally able to participate in this study\n3. Proper understanding of the Dutch language\n4. Signed informed consent\n5. Fractures to be treated with a short-arm cast without thumb inclusion for the period of 3 weeks (e.g. 2R3A1 = radial styloid avulsion, 2R3A2 = Simple radial fracture, 2U3A1 = Ulnar fracture of the base of the styloid process, 2U3A2= Simple distal ulna fracture, 2R3B1 = Intraarticular fracture of the styloid process of the radius (not displaced) or Triquetrum fracture (non AO classified))\n\nExclusion Criteria:\n\n1. Subject \\<18 years of age\n2. Pregnancy, breast feeding\n3. Participation in other clinical trials\n4. Patient is neither physically nor mentally able to participate in this study\n5. Non-intact skin in treatment area (including dermatological issues)\n6. Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound\n7. Medical treatment prior casting which could influence the microbiome\n8. Known Blood Circulatory Diseases\n9. Known Lymphedema or any general disorder of the lymphatic system\n10. Known Osteoporosis\n11. Known Diabetes\n12. Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease\n13. Intolerability or documented allergies against cast materials\n14. Subjects with not "normal" (unusual) hygienic behavior\n15. Suspected drug addiction or alcohol abuse\n16. Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects'}, 'identificationModule': {'nctId': 'NCT05347927', 'acronym': 'Microbiome II', 'briefTitle': 'Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome', 'organization': {'class': 'INDUSTRY', 'fullName': 'BSN Medical GmbH'}, 'officialTitle': 'Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome', 'orgStudyIdInfo': {'id': 'C2753'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test group', 'description': 'will receive water resistante padding and a cast', 'interventionNames': ['Device: water resistante padding']}, {'label': 'Control group', 'description': 'will receive traditional non-water resistante padding and cast', 'interventionNames': ['Device: non water resistante padding']}], 'interventions': [{'name': 'water resistante padding', 'type': 'DEVICE', 'description': '* Delta-Dry® Softliner\n* Tensoban®\n* Delta-Dry®', 'armGroupLabels': ['Test group']}, {'name': 'non water resistante padding', 'type': 'DEVICE', 'description': '* Delta-Net® Stockinette\n* Delta-Rol®', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9679 BJ', 'city': 'Groningen', 'state': 'Scheemda', 'country': 'Netherlands', 'facility': 'Ommelander Ziekenhuis', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '9401 RK', 'city': 'Assen', 'country': 'Netherlands', 'facility': 'Wilhelmina Ziekenhuis Assen (Assen, NL)', 'geoPoint': {'lat': 52.99667, 'lon': 6.5625}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum (Leiden, NL)', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BSN Medical GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}