Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-28 @ 11:48 PM
Study NCT ID:
NCT00590369
Status:
TERMINATED
Last Update Posted:
2012-04-02
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Negative Pressure Wound Therapy: Are All Systems Alike?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'albertn@ccf.org', 'phone': '216-444-7028', 'title': 'Nancy M. Albert PhD, RN', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'small sample size; early termination; did not reach expected sample size. Single center'}}, 'adverseEventsModule': {'timeFrame': 'duration of patient enrollment- generally 6 days; serious and/or other [non-serious] adverse events were collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'OG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'classes': [{'title': 'Depth of wound', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '3.0'}]}]}, {'title': 'Length of wound', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '13.8'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '21'}]}]}, {'title': 'Width of wound', 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5.5'}]}]}, {'title': 'Undermining of wound', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Tunneling of wound', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'first dressing change; typically within 48 hours', 'description': 'differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'SECONDARY', 'title': 'Ease of Performing Dressing Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'OG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '10.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during hospital stay; generally 6 days', 'description': 'responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'SECONDARY', 'title': 'Ease of Providing Nursing Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'OG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during hospital stay; generally 6 days', 'description': 'nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'SECONDARY', 'title': 'Cost of Wound Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'OG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'classes': [{'categories': [{'measurements': [{'value': '510.18', 'spread': '419.77', 'groupId': 'OG000'}, {'value': '333.54', 'spread': '71.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during hospital stay; generally 6 days', 'description': 'cost of device/supplies used in application and dressing changes', 'unitOfMeasure': 'dollars (USD)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'SECONDARY', 'title': 'Nursing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'OG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '38.8', 'spread': '19.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'hospital stay; generally 6 days', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'SECONDARY', 'title': 'Patient Reported Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'OG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at first dressing change; generally 48 hours', 'description': 'scale of 0= no pain to 10= worst pain possible', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'FG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Study stopped early due to difficulty recruiting subjects', 'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Jan 2006-March 2008; study recruitment; study stopped due to slow enrollment rate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KCI VAC', 'description': 'KCI VAC type negative pressure wound therapy device'}, {'id': 'BG001', 'title': 'Versatile One', 'description': 'Versatile One (EZCare)negative wound therapy device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'title': 'median', 'categories': [{'measurements': [{'value': '57', 'spread': '42, 58', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '58'}, {'value': '49', 'spread': '47, 50', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '50'}, {'value': '50', 'spread': '42, 58', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Recruitment challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-30', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-30', 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling', 'timeFrame': 'first dressing change; typically within 48 hours', 'description': 'differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler'}], 'secondaryOutcomes': [{'measure': 'Ease of Performing Dressing Change', 'timeFrame': 'during hospital stay; generally 6 days', 'description': 'responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do'}, {'measure': 'Ease of Providing Nursing Care', 'timeFrame': 'during hospital stay; generally 6 days', 'description': 'nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem'}, {'measure': 'Cost of Wound Care', 'timeFrame': 'during hospital stay; generally 6 days', 'description': 'cost of device/supplies used in application and dressing changes'}, {'measure': 'Nursing Time', 'timeFrame': 'hospital stay; generally 6 days'}, {'measure': 'Patient Reported Pain', 'timeFrame': 'at first dressing change; generally 48 hours', 'description': 'scale of 0= no pain to 10= worst pain possible'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wounds']}, 'descriptionModule': {'briefSummary': 'Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).', 'detailedDescription': "This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hospitalized adults requiring negative pressure dressings.\n\nExclusion Criteria:\n\n* Comatose\n* Mentally obtunded\n* Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function\n* Presence of Manufacturer's contraindications\n* Malignancy in wound\n* Untreated osteomyelitis\n* Unexplored fistula\n* Necrotic tissue\n* Exposed blood vessels or organs\n* Untreated malnutrition."}, 'identificationModule': {'nctId': 'NCT00590369', 'briefTitle': 'Negative Pressure Wound Therapy: Are All Systems Alike?', 'nctIdAliases': ['NCT00583141'], 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Negative Pressure Wound Therapy: Are All Systems Alike?', 'orgStudyIdInfo': {'id': '8309-c'}, 'secondaryIdInfos': [{'id': 'OSR 20050803'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'KCI VAC type negative pressure wound therapy device', 'interventionNames': ['Device: KCI -VAC']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Versatile One (EZCare) negative wound therapy device', 'interventionNames': ['Device: Versatile One (EZCare)']}], 'interventions': [{'name': 'KCI -VAC', 'type': 'DEVICE', 'description': 'Negative pressure wound therapy device', 'armGroupLabels': ['1']}, {'name': 'Versatile One (EZCare)', 'type': 'DEVICE', 'description': 'Negative pressure wound therapy device', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44107', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Nancy M Albert, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Nancy M. Albert PhD, RN', 'oldOrganization': 'Cleveland Clinic'}}}}