Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 8:16 PM
Study NCT ID:
NCT01171534
Status:
TERMINATED
Last Update Posted:
2018-01-29
First Post:
2010-07-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003161', 'term': 'Compartment Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dellaroccag@health.missouri.edu', 'phone': '573-882-6562', 'title': 'Gregory J. Della Rocca, MD, PhD, FACS', 'organization': 'University of Missouri, Department of Orthopaedic Surgery'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance of DermaClose System in Treatment of Fasciotomy Wounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure'}, {'id': 'OG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.'}], 'timeFrame': 'One year', 'description': 'Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation', 'reportingStatus': 'POSTED', 'populationDescription': 'Too low of an enrollment volume to analyze'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure'}, {'id': 'OG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.'}], 'timeFrame': 'One Year', 'description': 'Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'too low of an enrollment volume to analyze'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure'}, {'id': 'OG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.'}], 'timeFrame': 'One Year', 'description': 'Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated before any of this information was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure'}, {'id': 'OG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.'}], 'timeFrame': 'One year', 'description': 'Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated before this information was collected and analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure'}, {'id': 'FG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'retrospective arm never performed on study', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vessel Loop Fasciotomy Closure', 'description': 'Fasciotomy closure using vessel loops and staples.\n\nVessel loop: Vessel loops and staples for fasciotomy closure'}, {'id': 'BG001', 'title': 'DermaClose Fasciotomy Closure', 'description': 'Fasciotomy closure via DermaClose device\n\nDermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Study determined not to be feasible to continue.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2010-07-27', 'resultsFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-03', 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of DermaClose System in Treatment of Fasciotomy Wounds', 'timeFrame': 'One year', 'description': 'Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'One Year', 'description': 'Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months'}, {'measure': 'Quality of Life', 'timeFrame': 'One Year', 'description': 'Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months'}, {'measure': 'Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure', 'timeFrame': 'One year', 'description': 'Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wounds and Injuries', 'Compartment Syndrome']}, 'descriptionModule': {'briefSummary': 'Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery.\n\nNull hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques.\n\nNull hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.', 'detailedDescription': 'After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer\'s instructions, or through application of vessel loops with staples in a "shoestring technique" as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Patients undergoing fasciotomy for decompression of compartment syndrome, evolving compartment syndrome, or prophylactically to prevent compartment syndrome\n\nExclusion Criteria:\n\n* Patient younger than 18 years of age\n* Patients with an active infection\n* Patients unable to comply with protocol'}, 'identificationModule': {'nctId': 'NCT01171534', 'briefTitle': 'Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander', 'orgStudyIdInfo': {'id': 'IRB1162817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vessel Loop fasciotomy closure', 'description': 'Fasciotomy closure using vessel loops and staples.', 'interventionNames': ['Device: Vessel loop']}, {'type': 'EXPERIMENTAL', 'label': 'DermaClose fasciotomy closure', 'description': 'Fasciotomy closure via DermaClose device', 'interventionNames': ['Device: DermaClose fasciotomy closure']}], 'interventions': [{'name': 'DermaClose fasciotomy closure', 'type': 'DEVICE', 'otherNames': ['Continuous External Tissue Expander'], 'description': 'The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.', 'armGroupLabels': ['DermaClose fasciotomy closure']}, {'name': 'Vessel loop', 'type': 'DEVICE', 'description': 'Vessel loops and staples for fasciotomy closure', 'armGroupLabels': ['Vessel Loop fasciotomy closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Hospital and Clinics', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Gregory J Della Rocca, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wound Care Technologies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Co-Director of Trauma Services, Department of Orthopaedic Surgery', 'investigatorFullName': 'Gregory Della Rocca', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}