Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT01355666
Status:
UNKNOWN
Last Update Posted:
2011-05-18
First Post:
2011-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041342', 'term': 'Absorbent Pads'}], 'ancestors': [{'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-17', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-17', 'lastUpdatePostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention and reduction in the incidence of pressure ulcers', 'timeFrame': 'Weekly assessments for 1 year', 'description': 'The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.'}], 'secondaryOutcomes': [{'measure': 'Reduction of bacterial contamination', 'timeFrame': 'Weekly for 8 weeks', 'description': "To evaluate the effectiveness of DermaTherapy® bedding to reduce the potential for bacterial contamination associated with patients' bed linens and thereby help reduce the incidence of facility-acquired infections."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pressure ulcers', 'stage 1', 'stage 2', 'stage 3', 'stage 4', 'wounds', 'sores', 'infection', 'bioburden', 'bacterial contamination', 'bed linen', 'sheets', 'underpad', 'skin assessment', 'microclimate', 'shear', 'friction', 'moisture', 'fabrics', 'long term care', 'nursing home', 'decubitus ulcer', 'bed ridden', 'anti-microbial'], 'conditions': ['Pressure Ulcers']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.', 'detailedDescription': "Additional objectives of this research study are:\n\n* To evaluate healing of pressure ulcers already present or pressure ulcers that develop during the study.\n* To evaluate the effectiveness of DermaTherapy® bedding and alternative diapers to reduce the potential for bacterial contamination associated with patients' bed linens, underpads, gowns and pajamas, and thereby help reduce the incidence of facility-acquired infections.\n\nStudy nurses will assess the skin of the subjects once or twice a week for the presence of pressure ulcers and measure the size of the pressure ulcers if they are present. Study nurses will also obtain bacterial culture swabs of the bedding weekly for the first eight weeks of the study from five participants in each group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents admitted for long term care.\n* Residents admitted for Hospice Care with an expected length of stay greater than one week.\n* Residents with an expected length of stay equal to or greater than 90 days.'}, 'identificationModule': {'nctId': 'NCT01355666', 'briefTitle': 'Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting', 'organization': {'class': 'OTHER', 'fullName': 'Precision Fabrics Group, Inc.'}, 'officialTitle': 'Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting', 'orgStudyIdInfo': {'id': 'DermaTherapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DermaTherapy® Linen group', 'description': 'The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.', 'interventionNames': ['Device: DermaTherapy® Linen and underpads.']}], 'interventions': [{'name': 'DermaTherapy® Linen and underpads.', 'type': 'DEVICE', 'otherNames': ['DermaTherapy®'], 'description': 'DermaTherapy® Linen is a 100% synthetic silk-like fabric technology designed to provide a cleaner, drier and smoother surface between the skin and support systems for a healthy micro-climate.\n\nSubjects in the DermaTherapy® Linen Group are compared to subjects receiving usual care - bed linen made of cotton-blend fabrics.', 'armGroupLabels': ['DermaTherapy® Linen group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jack I Twersky, MD', 'role': 'CONTACT', 'email': 'jack.twersky@va.gov', 'phone': '919-286-0411', 'phoneExt': '7750'}, {'name': 'Kenneth E Schmader, MD', 'role': 'CONTACT', 'email': 'kenneth.schmader@va.gov', 'phone': '919-286-0411', 'phoneExt': '6769'}, {'name': 'Jack I Twersky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Durham VA Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Jack I Twersky, MD', 'role': 'CONTACT', 'email': 'jack.twersky@ya.gov', 'phone': '919-286-0411', 'phoneExt': '7750'}, {'name': 'Kenneth E Schmader, MD', 'role': 'CONTACT', 'email': 'kenneth.schmader@va.gov', 'phone': '919-286-0411', 'phoneExt': '6769'}], 'overallOfficials': [{'name': 'Jack I Twersky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Duke University Medical Center'}, {'name': 'Kenneth E Schmader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA medical Center, Duke University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Precision Fabrics Group, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'Dr. Terry Montgomery', 'oldOrganization': 'Precision Fabrics Group, inc.'}}}}