Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT01417234
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2011-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jane.hart@acelity.com', 'phone': '12102555595', 'title': 'VP, Global Clinical Development', 'organization': 'KCI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wound Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Percent of subjects with study wound deemed closed at 12 weeks\n\n1 wound is studied per participant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population used for analysis. 3 subjects withdrew from study early due to non-compliance with study therapy and were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Wound Size Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-41', 'spread': '0.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Wound Size Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.2', 'spread': '0.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 8 weeks', 'description': 'Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Wound Size Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks and 12 weeks', 'description': 'Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Subject non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SNaP® Wound Care System', 'description': 'SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '55', 'spread': '11.94', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2011-08-12', 'resultsFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2011-08-12', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-15', 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Closure', 'timeFrame': '12 weeks', 'description': 'Percent of subjects with study wound deemed closed at 12 weeks\n\n1 wound is studied per participant'}], 'secondaryOutcomes': [{'measure': 'Percent Wound Size Change', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)'}, {'measure': 'Percent Wound Size Change', 'timeFrame': '4 weeks and 8 weeks', 'description': 'Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)'}, {'measure': 'Percent Wound Size Change', 'timeFrame': '8 weeks and 12 weeks', 'description': 'Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Trauma-related Wound', 'Surgical Wound, Recent']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from exisiting investigator patient population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities\n* Wound \\< 16 cm in greatest diameter\n* Subject ≥ 18 years of age\n* Exudate \\< 25 ml/ day (estimate)\n* Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study\n* Subject is willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Wound \\> 45 days old\n* Wound-related cellulitis\n* Wound located in an area not amenable to forming an air-tight seal\n* Subject has untreated osteomyelitis\n* Subject is allergic to wound care products\n* Wound has exposed blood vessels not suitable for negative pressure therapy\n* Subject is pregnant\n* Subject is actively participating in other clinical trials that conflict with current study\n* Subject has fistulas'}, 'identificationModule': {'nctId': 'NCT01417234', 'briefTitle': 'Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': '3M'}, 'officialTitle': 'Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds', 'orgStudyIdInfo': {'id': '102110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SNaP® Wound Care System', 'interventionNames': ['Device: SNaP® Wound Care System']}], 'interventions': [{'name': 'SNaP® Wound Care System', 'type': 'DEVICE', 'description': 'Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.', 'armGroupLabels': ['SNaP® Wound Care System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41955', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3M', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}