Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01061502
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2010-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-09', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare epithelialization over time', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To compare patient reported perception of pain', 'timeFrame': '3 months'}, {'measure': 'To compare scarring', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Burns', 'Wounds and Injuries', 'Skin Grafts, Bioelectric', 'Grafting, skin'], 'conditions': ['Burns', 'Wound Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Wounds resulting from skin graft\n* Split thickness wound\n* Wound size greater than 2x2 cm\n* Wounds must be ≥5 cm away from all other wounds\n* Participant agrees to participate in follow-up evaluation\n* Participant must be able to read and understand informed consent, and sign the informed consent\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study\n* Participant is to receive another topical antimicrobial agent other than the study dressing\n* Participant with sensitivity or adverse reactions to silver or zinc\n* Pregnancy or nursing an infant or child\n* Immunosuppression\n* Active or systemic infection\n* Peripheral vascular occlusive disease\n* Collagen vascular disease\n* Connective tissue disease\n* Participant undergoing active cancer chemotherapy\n* Chronic steroid use\n* Decision impairment'}, 'identificationModule': {'nctId': 'NCT01061502', 'briefTitle': 'Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vomaris Innovations'}, 'officialTitle': 'Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites', 'orgStudyIdInfo': {'id': 'XSMP-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procellera Wound Dressing', 'description': 'Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed', 'interventionNames': ['Device: Procellera (Bioelectric Wound Dressing)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opsite Transparent Adhesive Dressing', 'description': 'Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed', 'interventionNames': ['Device: Opsite (Transparent Adhesive Dressing)']}], 'interventions': [{'name': 'Procellera (Bioelectric Wound Dressing)', 'type': 'DEVICE', 'otherNames': ['Procellera', 'PROSIT', 'Procellera Wound Dressing', 'Procellera Device'], 'description': 'Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed', 'armGroupLabels': ['Procellera Wound Dressing']}, {'name': 'Opsite (Transparent Adhesive Dressing)', 'type': 'DEVICE', 'otherNames': ['Opsite Dressing'], 'description': 'Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.', 'armGroupLabels': ['Opsite Transparent Adhesive Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Blodgett Hospital', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Andrew L Blount, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blodgett Hospital'}, {'name': 'Richard Wilcox, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Blodgett Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vomaris Innovations', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Andrew Blount, MD', 'oldOrganization': 'Spectrum Health Blodgett Hospital'}}}}