Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-12 @ 11:16 PM
Study NCT ID:
NCT02289157
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2014-10-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Negative Pressure Wound Therapy in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'scott.roberts@utsouthwestern.edu', 'phone': '214-648-3113', 'title': 'Dr. Scott Roberts', 'organization': 'UTSW Medical Center'}, 'certainAgreement': {'otherDetails': '8\\. PUBLICATION AND REPORTS ON DATA; COPYRIGHTS\n\nA. Prior to public presentation or submission to a journal, Investigator will submit for review to Company...content of any manuscript for publication, abstract, or presentation containing data and results of the Study, ...such review is for the limited purposes of ensuring that the manuscript accurately describes the Product and does not contain any Confidential lnformation...Investigator will have the unfettered right to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 0, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Wound Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of surgery to 30 days postoperative', 'description': 'Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Classification of Wound Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'title': 'Dehiscence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cellulitis', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Superficial incisional SSI', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Deep incisional SSI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Organ space infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Pearson Chi-squared, df (3)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Postoperative Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Length of Postoperative Stay', 'description': 'Number of Days in Hospital after Initial Surgery', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay After Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '22'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'After dismissal and readmitted within 30 days for wound morbidity', 'description': 'Number of days in hospital after readmission for wound morbidity', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Emergency Room Visits After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'No ER visits', 'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}, {'title': '1 ER visit', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': '2 ER visits', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of surgery to 30 days postoperative', 'description': 'Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Number of Clinic Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'title': '1 visit', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '2 visits', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '3 visits', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4 visits', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '5 visits', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery to 30 days postoperative', 'description': 'Number of clinic visits made by patients after surgery concerning wound morbidity per patient', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Morbid Outcomes After Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'title': 'Readmission', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative antimicrobials', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Reoperation for I and D/Extirpation', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Scheduled and Unscheduled Cesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'Scheduled', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Unscheduled', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'pfannenstiel', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'midline', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'Ruptured', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Unruptured', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Labor Versus no Labor Prior to Cesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'Labor', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'No labor', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Hypertension Versus no Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'Hypertension', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'No Hypertension', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'Insulin Diabetes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No Diabetes', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Chorioamnionitis Versus no Chorioamnionitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'classes': [{'categories': [{'title': 'chorioamnionitis', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'no chorioamnionitis', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'FG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'No Post op Check or Follow up Phone Call', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited in the Parkland Hospital Maternal-Fetal Medicine High Risk Clinic, on the Antepartum Floor, in Labor and Delivery, and in the preoperative holding area. January 2015 until July 2016. 850 screened. See Figure 1 Flow Diagram.', 'preAssignmentDetails': 'Patients were excluded for pre-specified exclusion criteria and if they delivered vaginally after consent was obtained. 850 patients were screened. 173 declined participation, 5 withdrew consent, 2 delivered at outside facility, 211 delivered vaginally, 10 did not meet inclusion criteria, and 8 not identified to be enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.\n\nNegative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.'}, {'id': 'BG001', 'title': 'Standard Dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '30.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '29.7', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race Black', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'Race Hispanic', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}]}, {'title': 'Race White', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age at delivery', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity', 'classes': [{'title': 'Parity 0', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Parity 1', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}, {'title': 'Parity 2', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'Parity > 2', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of deliveries after 20 weeks prior to the present delivery', 'unitOfMeasure': 'participants'}, {'title': 'BMI at Delivery', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '46.3', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BMI = kg/meter^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tobacco use', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of smokers in each arm numbers', 'unitOfMeasure': 'participants'}, {'title': 'Chronic hypertension', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insulin Requiring Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Cesarean', 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cesarean Priority', 'classes': [{'title': 'Scheduled', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'ASAP', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}, {'title': 'Emergent', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Length of Surgery', 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000', 'lowerLimit': '70', 'upperLimit': '103'}, {'value': '80', 'groupId': 'BG001', 'lowerLimit': '64', 'upperLimit': '99'}, {'value': '82', 'groupId': 'BG002', 'lowerLimit': '67', 'upperLimit': '101'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Estimated blood loss', 'classes': [{'categories': [{'measurements': [{'value': '1181', 'spread': '294', 'groupId': 'BG000'}, {'value': '1136', 'spread': '285', 'groupId': 'BG001'}, {'value': '1159', 'spread': '291', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Midline skin incision', 'classes': [{'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Suture skin closure', 'classes': [{'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Subcutaneous skin depth in cm', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '5.4', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number subcutaneous layers closed', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'layers', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Incision length in cm', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patients in labor prior cesarean', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Induction Labor', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ruptured Membranes', 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chorioamnionitis', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Placebo Controlled Clinical Trial - Open Label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2014-10-06', 'resultsFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-31', 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Wound Complication', 'timeFrame': 'Day of surgery to 30 days postoperative', 'description': 'Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.'}, {'measure': 'Number of Participants With Classification of Wound Morbidity', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI'}], 'secondaryOutcomes': [{'measure': 'Length of Postoperative Stay', 'timeFrame': 'Length of Postoperative Stay', 'description': 'Number of Days in Hospital after Initial Surgery'}, {'measure': 'Length of Stay After Readmission', 'timeFrame': 'After dismissal and readmitted within 30 days for wound morbidity', 'description': 'Number of days in hospital after readmission for wound morbidity'}, {'measure': 'Number of Patients With Emergency Room Visits After Discharge', 'timeFrame': 'Day of surgery to 30 days postoperative', 'description': 'Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.'}, {'measure': 'Number of Patients With Number of Clinic Visits', 'timeFrame': 'Day of surgery to 30 days postoperative', 'description': 'Number of clinic visits made by patients after surgery concerning wound morbidity per patient'}, {'measure': 'Number of Participants With Morbid Outcomes After Delivery', 'timeFrame': 'Day of Surgery to 30 days postoperative'}, {'measure': 'Number of Participants With Scheduled and Unscheduled Cesarean Section', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity'}, {'measure': 'Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity'}, {'measure': 'Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes'}, {'measure': 'Number of Patients in Labor Versus no Labor Prior to Cesarean Section', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor'}, {'measure': 'Number of Patients With Hypertension Versus no Hypertension', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity'}, {'measure': 'Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.'}, {'measure': 'Number of Patients With Chorioamnionitis Versus no Chorioamnionitis', 'timeFrame': 'Day of Surgery to 30 days postoperative', 'description': 'Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Postoperative Wound Complications']}, 'referencesModule': {'references': [{'pmid': '31503147', 'type': 'DERIVED', 'citation': 'Hussamy DJ, Wortman AC, McIntire DD, Leveno KJ, Casey BM, Roberts SW. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4):781-789. doi: 10.1097/AOG.0000000000003465.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .', 'detailedDescription': "This will be a prospective, randomized, controlled trial of pregnant women who present for prenatal care at Parkland Health and Hospital System. The participants will be limited to women undergoing a cesarean section who are high risk for wound complications: all patients with a BMI \\> 40 undergoing cesarean section.\n\nThe primary outcome will be wound complication defined as wound disruption or wound infection. A wound disruption will be defined as the partial or complete opening of the deep subcutaneous space, not to include superficial skin separation. Underlying causes will include seroma, hematoma, abscess, and facial dehiscence. Wound infection will be defined as a physician diagnosis of wound infection with erythema and warmth extending beyond the immediate area adjacent to the incision and requiring treatment with antibiotics.\n\nAll patients with a BMI \\> 40 undergoing scheduled cesarean section and patients with a BMI \\>40 who are admitted in labor will be approached to participate in the study. If patients meeting this criteria undergo cesarean section, they will be randomized to negative pressure wound therapy or a standard dressing. All labor treatment, pre-operative antibiotics, surgical technique, and post-operative care will not differ from current standard of care. All patients randomized will be included in the study.\n\nAll study participants will have the thickness of their subcutaneous tissue measured with a sterile ruler. Patients randomized to NPWT will have a negative pressure wound therapy system placed over her incision per the manufacturer's protocol. All patients randomized to standard dressing will have the customary dressing of gauze and surgical tape placed over her incision.\n\nThe investigators will be utilizing a single use negative pressure wound therapy system for the study. Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use.\n\nAll randomized patients will undergo an examination of their incision by a research physician or nurse prior to discharge. The NPWT will be removed prior to discharge or on post-operative day seven, whichever comes first. All postpartum patients who undergo a cesarean delivery are inpatients until at least post-operative day three and will continue use of NPWT until day of discharge. In patients randomized to a standard dressing, the dressing will be removed prior to discharge per current standard of care.\n\nAll randomized patients will also undergo a 2 week post-operative incisional examination by a research physician or nurse at the obstetrical complications clinic. Patients will be followed until 30 days postpartum for any wound complications to include wound infection (superficial and deep), readmission to the hospital, re-operation for wound complications, hematoma, seroma, dehiscence, superficial infection requiring antibiotics, or additional clinical evaluations for wound care in the emergency room or clinic setting. A research physician or nurse will contact each after at least 30 days post-operative to confirm the patients' status and ensure no evaluations, admissions, or interventions were done at outside facilities.\n\nSubjects will exit the study if they are unable to complete the post-operative visit or withdrawal consent for participation."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women with BMI \\> 40 undergoing a cesarean delivery at Parkland Health and Hospital System.\n\nExclusion Criteria:\n\n* Any patient not meeting inclusion criteria will be deemed ineligible.\n* All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.\n* Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.\n* according to the wound therapy manufacturer's instructions patients with:\n\n * fragile skin\n * allergy to silver or acrylic adhesives\n * a malignancy in the wound bed or margins of the wound bed\n * non-enteric and unexplored fistulas\n * necrotic tissue with eschar present\n * exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device."}, 'identificationModule': {'nctId': 'NCT02289157', 'acronym': 'NPWTCS', 'briefTitle': 'Negative Pressure Wound Therapy in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean', 'orgStudyIdInfo': {'id': 'STU 042014-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Negative Pressure Wound Therapy', 'description': 'After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.', 'interventionNames': ['Device: Negative pressure wound therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard dressing', 'description': 'After standard cesarean section completed patients will have standard dressing placed.'}], 'interventions': [{'name': 'Negative pressure wound therapy', 'type': 'DEVICE', 'otherNames': ['Prevena'], 'description': 'Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.', 'armGroupLabels': ['Negative Pressure Wound Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Scott Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCI USA, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}