Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-01 @ 2:43 AM
Study NCT ID:
NCT02799667
Status:
TERMINATED
Last Update Posted:
2021-02-21
First Post:
2016-05-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apeterson@tuftsmedicalcenter.org', 'phone': '617-636-5000', 'title': 'Ashley T. Peterson, MD, Study Coordinator', 'phoneExt': '2382', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination secondary to slow recruitment.'}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.\n\nNegative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.\n\nNegative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post partum/post operative period', 'description': 'Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.\n\nNegative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure.'}], 'classes': [{'title': 'superficial SSI', 'categories': [{'title': 'yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'deep SSI', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'organ space SSI', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'skin blisters', 'categories': [{'title': 'yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'scar separation', 'categories': [{'title': 'yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'seroma w/evacuation', 'categories': [{'title': 'yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'hematoma w/evacuation', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'wound debridement', 'categories': [{'title': 'yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'hospital readmission', 'categories': [{'title': 'yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'additional operative room management', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post partum/post operative period', 'description': 'The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.\n\nNegative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post partum/post operative period', 'description': 'Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \\> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.\n\nNegative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post partum/post operative period', 'description': 'Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.'}, {'id': 'OG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.\n\nNegative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure.'}], 'classes': [{'title': 'superficial SSI', 'categories': [{'title': 'yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'deep SSI', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'organ space SSI', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'skin blisters', 'categories': [{'title': 'yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'scar separation', 'categories': [{'title': 'yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'seroma w/evacuation', 'categories': [{'title': 'yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'hematoma w/evacuation', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'wound debridement', 'categories': [{'title': 'yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'hospital readmission', 'categories': [{'title': 'yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'additional operative room management', 'categories': [{'title': 'yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'no', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post partum/post operative period', 'description': 'The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment 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'5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post partum/post operative period', 'description': 'Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \\> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.\n\nStandard Dressing: Patients are randomized to the standard dressing at the time of fascial closure.'}, {'id': 'FG001', 'title': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the 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{'value': '110', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, 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'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'pregestational diabetes', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'current smoker', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'former smoker', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'chronic steroid use', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin use', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Oral Hypoglycemic agent use', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-08', 'size': 397241, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-09-03T08:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2016-05-20', 'resultsFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-18', 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment', 'timeFrame': '2 weeks post partum/post operative period', 'description': 'Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment', 'timeFrame': '2 weeks post partum/post operative period', 'description': 'The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.'}, {'measure': 'Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment', 'timeFrame': '2 weeks post partum/post operative period', 'description': 'Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \\> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.'}, {'measure': 'Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.', 'timeFrame': '6 weeks post partum/post operative period', 'description': 'Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.'}, {'measure': 'Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively', 'timeFrame': '6 weeks post partum/post operative period', 'description': 'The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \\>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.'}, {'measure': 'Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively', 'timeFrame': '6 weeks post partum/post operative period', 'description': 'Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \\> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['negative pressure wound therapy', 'cesarean delivery'], 'conditions': ['Obesity', 'Surgical Site Infections', 'Wound Complications', 'Complications; Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '34058423', 'type': 'DERIVED', 'citation': 'Peterson AT, Bakaysa SL, Driscoll JM, Kalyanaraman R, House MD. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100410. doi: 10.1016/j.ajogmf.2021.100410. Epub 2021 May 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \\> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.', 'detailedDescription': 'Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI \\> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.\n\nExclusion Criteria:\n\n* Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI \\< 40 kg/m2 will be excluded from this study.'}, 'identificationModule': {'nctId': 'NCT02799667', 'briefTitle': 'Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center?', 'orgStudyIdInfo': {'id': '11943'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dressing', 'description': 'Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.', 'interventionNames': ['Device: Standard Dressing']}, {'type': 'EXPERIMENTAL', 'label': 'Negative Pressure Wound Therapy Dressing', 'description': 'Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.', 'interventionNames': ['Device: Negative Pressure Wound Therapy Dressing']}], 'interventions': [{'name': 'Standard Dressing', 'type': 'DEVICE', 'description': 'Patients are randomized to the standard dressing at the time of fascial closure.', 'armGroupLabels': ['Standard Dressing']}, {'name': 'Negative Pressure Wound Therapy Dressing', 'type': 'DEVICE', 'description': 'Patients are randomized to the NPWT at the time of fascial closure.', 'armGroupLabels': ['Negative Pressure Wound Therapy Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael House, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center, physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}