Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT02020018
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schaff.hartzell@mayo.edu', 'phone': '507-255-7066', 'title': 'Dr. Hartzell V. Schaff', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 30 days postoperatively.', 'eventGroups': [{'id': 'EG000', 'title': 'Prospective Group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.', 'otherNumAtRisk': 272, 'deathsNumAtRisk': 272, 'otherNumAffected': 0, 'seriousNumAtRisk': 272, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Retrospective Arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.', 'otherNumAtRisk': 1597, 'deathsNumAtRisk': 1597, 'otherNumAffected': 0, 'seriousNumAtRisk': 1597, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wound Infection After Open Heart Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '1597', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.'}, {'id': 'OG001', 'title': 'Retrospective Arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-surgery', 'description': 'The total number of participants with surgical site infections after cardiac surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reoperation for Wound Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.'}, {'id': 'OG001', 'title': 'Retrospective Arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.'}], 'timeFrame': '30 days post surgery', 'description': 'The total number of reoperations required due to infection.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on reoperation was not collected.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.'}, {'id': 'OG001', 'title': 'Retrospective Arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.'}], 'timeFrame': 'postoperative to discharge', 'description': 'Length of stay was defined as the number of nights spent in the hospital after surgery.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prospective Group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.'}, {'id': 'FG001', 'title': 'Retrospective Arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '1597'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '1597'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '1597', 'groupId': 'BG001'}, {'value': '1869', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prospective Group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.'}, {'id': 'BG001', 'title': 'Retrospective Arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '1597', 'groupId': 'BG001'}, {'value': '1869', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '1597', 'groupId': 'BG001'}, {'value': '1869', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '518', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '1079', 'groupId': 'BG001'}, {'value': '1258', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '1597', 'groupId': 'BG001'}, {'value': '1869', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '1597', 'groupId': 'BG001'}, {'value': '1869', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-23', 'size': 167014, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-26T14:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1869}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2013-12-18', 'resultsFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-05', 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'postoperative to discharge', 'description': 'Length of stay was defined as the number of nights spent in the hospital after surgery.'}], 'primaryOutcomes': [{'measure': 'Wound Infection After Open Heart Surgery', 'timeFrame': '30 days post-surgery', 'description': 'The total number of participants with surgical site infections after cardiac surgery.'}], 'secondaryOutcomes': [{'measure': 'Reoperation for Wound Infection', 'timeFrame': '30 days post surgery', 'description': 'The total number of reoperations required due to infection.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Wound Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.', 'detailedDescription': 'Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Transplant patients\n2. BMI \\>30\n3. Type I (insulin-dependent) diabetics\n4. Severe chronic obstructive pulmonary disease (COPD)\n5. Steroid-dependent patients\n6. Previous Tracheostomy\n\nExclusion criteria:\n\n1. BMI\\<30\n2. Thoracotomy'}, 'identificationModule': {'nctId': 'NCT02020018', 'briefTitle': 'Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery', 'orgStudyIdInfo': {'id': '16-007901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective group', 'description': 'Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.', 'interventionNames': ['Device: Prevena Incision Management System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retrospective arm', 'description': 'Conventional sterile dry wound dressing applied immediately postoperatively.', 'interventionNames': ['Other: Conventional sterile dry wound dressing']}], 'interventions': [{'name': 'Prevena Incision Management System', 'type': 'DEVICE', 'otherNames': ['negative pressure therapy', 'wound VAC', 'Prevena'], 'description': 'negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days', 'armGroupLabels': ['Prospective group']}, {'name': 'Conventional sterile dry wound dressing', 'type': 'OTHER', 'otherNames': ['poststernotomy wound dressing', 'standard dressing after sternotomy'], 'description': 'regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy', 'armGroupLabels': ['Retrospective arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Hartzell V Schaff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCI USA, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Hartzell V. Schaff', 'investigatorAffiliation': 'Mayo Clinic'}}}}