Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-04 @ 8:10 PM
Study NCT ID:
NCT02461433
Status:
TERMINATED
Last Update Posted:
2019-02-26
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bmalas1@jhmi.edu', 'phone': '410-550-4546', 'title': 'Mahmoud Malas', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From consent to end of study (30 days)', 'description': 'Used a checklist to inquire about would feeling, and systemic effects', 'eventGroups': [{'id': 'EG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days postop', 'description': 'The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery', 'unitOfMeasure': 'Surgical Site infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Wound Complications (Aggregate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days postop', 'description': 'Dehiscence, seroma and hematoma. Reported as number of aggregate events.', 'unitOfMeasure': 'aggregate wound complication events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Bacterial Count as Assessed by Microbacterial Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'timeFrame': 'Up to 7 days postop', 'description': 'Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count', 'reportingStatus': 'POSTED', 'populationDescription': 'The samples were not sent to the lab'}, {'type': 'SECONDARY', 'title': 'Physical Function as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days postop', 'description': 'Readmission events for the patients.', 'unitOfMeasure': 'readmission events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Functioning as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Energy / Fatigue as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emotional Well Being as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '60'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'General Health as Assessed by Short Form Survey (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'FG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).\n\nPrevena: Prevena Incision Management system'}, {'id': 'BG001', 'title': 'Standard Dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.\n\nStandard Dressing: This involves standard of care dressing including but not limited to gauze.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '34'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '45'}, {'value': '39.5', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Location of where the participant was enrolled.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-05', 'size': 1546615, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-02T10:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Sponsor pulled funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2015-06-01', 'resultsFirstSubmitDate': '2017-10-05', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-02', 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines', 'timeFrame': 'Up to 7 days postop', 'description': 'The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery'}], 'secondaryOutcomes': [{'measure': 'Other Wound Complications (Aggregate)', 'timeFrame': 'Up to 14 days postop', 'description': 'Dehiscence, seroma and hematoma. Reported as number of aggregate events.'}, {'measure': 'Skin Bacterial Count as Assessed by Microbacterial Count', 'timeFrame': 'Up to 7 days postop', 'description': 'Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count'}, {'measure': 'Physical Function as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}, {'measure': 'Readmissions', 'timeFrame': 'Up to 30 days postop', 'description': 'Readmission events for the patients.'}, {'measure': 'Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}, {'measure': 'Social Functioning as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}, {'measure': 'Energy / Fatigue as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}, {'measure': 'Emotional Well Being as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}, {'measure': 'Pain as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}, {'measure': 'General Health as Assessed by Short Form Survey (SF) 36', 'timeFrame': 'Up to 14 days postop', 'description': 'The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Obesity', 'Obese', 'surgical site infection', 'closed incisions', 'negative pressure therapy'], 'conditions': ['Wound Infection, Surgical', 'Obesity', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.', 'detailedDescription': 'In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.\n\nThe investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.\n* Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.\n* Patient with BMI≥ 30 at the time of surgery\n* Patient agrees to return for all required clinical follow up for the study.\n\nExclusion Criteria:\n\n* Known allergic reaction to acrylic adhesives or silver.\n* Known history of intolerance to any component of Prevena Incision Management System TM.\n* Very fragile skin around incision site.\n* Bleeding disorder or refuses blood transfusion.\n* Malignancy or other condition limiting life expectancy to \\<5 years.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02461433', 'acronym': 'SAVIOR', 'briefTitle': 'Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications', 'orgStudyIdInfo': {'id': 'IRB00030337'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevena', 'description': 'After surgery this group will receive the Prevena device (negative pressure wound therapy).', 'interventionNames': ['Device: Prevena']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dressing', 'description': 'After surgery this group will receive standard of care dressings on their surgical wound.', 'interventionNames': ['Device: Standard Dressing']}], 'interventions': [{'name': 'Prevena', 'type': 'DEVICE', 'description': 'Prevena Incision Management system', 'armGroupLabels': ['Prevena']}, {'name': 'Standard Dressing', 'type': 'DEVICE', 'description': 'This involves standard of care dressing including but not limited to gauze.', 'armGroupLabels': ['Standard dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medical Institutes', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Kimberley Steele, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kinetic Concepts, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}