Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-03-25 @ 8:54 AM
Study NCT ID:
NCT03269968
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D007239', 'term': 'Infections'}]}, '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': 'rachael.overcash@medstar.net', 'phone': '202-877-6093', 'title': 'Rachael Overcash', 'organization': 'MedStar Health Reseach Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The study was terminated due to insufficient enrollment. No study data are available.', 'description': 'The study was terminated due to insufficient enrollment. No study data are available.', 'eventGroups': [{'id': 'EG000', 'title': 'Negative Pressure Wound Therapy (NPWT)', 'description': 'Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.\n\nNegative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Dressing', 'description': 'Standard dressing\n\nStandard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Wound Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy (NPWT)', 'description': 'Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.\n\nNegative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'Standard dressing\n\nStandard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.'}], 'timeFrame': 'Four weeks postpartum', 'description': 'Any of wound infection, seroma/hematoma, wound separation \\>1 cm, and wound dehiscence', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to insufficient enrollment. No study data are available.'}, {'type': 'SECONDARY', 'title': 'Patient Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy (NPWT)', 'description': 'Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.\n\nNegative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.'}, {'id': 'OG001', 'title': 'Standard Dressing', 'description': 'Standard dressing\n\nStandard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.'}], 'timeFrame': 'Four weeks postpartum', 'description': "Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to insufficient enrollment. No study data are available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Demographic Data', 'timeFrame': 'At time time of admission', 'description': 'Age, race/ethnicity, parity', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maternal Body Mass Index', 'timeFrame': 'At time time of admission', 'description': 'Prepregnancy and at the time of delivery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gestational Age at Delivery', 'timeFrame': 'At time time of admission', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maternal Comorbidities', 'timeFrame': 'At time time of admission', 'description': 'Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Antenatal Complications', 'timeFrame': 'At time time of admission', 'description': 'Gestational diabetes, preeclampsia', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Previous Cesarean Deliveries', 'timeFrame': 'At time time of admission', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Indication for Cesarean Delivery', 'timeFrame': 'At time time of cesarean delivery', 'description': 'Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reason for Admission', 'timeFrame': 'At the time of admission', 'description': 'Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Labor Duration', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Endometritis', 'timeFrame': 'Four weeks postpartum', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Rupture of Membranes', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Operative Time', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intraoperative Complication', 'timeFrame': 'At the time of cesarean delivery', 'description': 'Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Skin Incision', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Uterine Incision', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Fascia Closure', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Subcutaneous Closure', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Administration of Preoperative Antibiotics', 'timeFrame': 'At the time of cesarean delivery', 'description': 'Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quantitative Blood Loss', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Negative Pressure Wound Therapy (NPWT)', 'description': 'Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.\n\nNegative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.'}, {'id': 'FG001', 'title': 'Standard Dressing', 'description': 'Standard dressing\n\nStandard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study was terminated due to insufficient enrollment. No study data are available.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Negative Pressure Wound Therapy (NPWT)', 'description': 'Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.\n\nNegative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.'}, {'id': 'BG001', 'title': 'Standard Dressing', 'description': 'Standard dressing\n\nStandard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Race and Ethnicity Not Collected', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}, {'title': 'Parity'}], 'populationDescription': 'The study was terminated due to insufficient enrollment. No study data are available.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-09-24', 'size': 51004, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2020-09-24T13:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study participants will be enrolled in a 1:1 ratio to either Negative Pressure Wound Therapy or standard dressing. Randomization will occur prior to delivery using a computer randomization system.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Recruitment difficulty', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2017-08-30', 'resultsFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-24', 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demographic Data', 'timeFrame': 'At time time of admission', 'description': 'Age, race/ethnicity, parity'}, {'measure': 'Maternal Body Mass Index', 'timeFrame': 'At time time of admission', 'description': 'Prepregnancy and at the time of delivery'}, {'measure': 'Gestational Age at Delivery', 'timeFrame': 'At time time of admission', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Maternal Comorbidities', 'timeFrame': 'At time time of admission', 'description': 'Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism'}, {'measure': 'Antenatal Complications', 'timeFrame': 'At time time of admission', 'description': 'Gestational diabetes, preeclampsia'}, {'measure': 'Number of Previous Cesarean Deliveries', 'timeFrame': 'At time time of admission', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Indication for Cesarean Delivery', 'timeFrame': 'At time time of cesarean delivery', 'description': 'Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean'}, {'measure': 'Reason for Admission', 'timeFrame': 'At the time of admission', 'description': 'Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)'}, {'measure': 'Labor Duration', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Endometritis', 'timeFrame': 'Four weeks postpartum', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Length of Rupture of Membranes', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Operative Time', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Intraoperative Complication', 'timeFrame': 'At the time of cesarean delivery', 'description': 'Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy'}, {'measure': 'Type of Skin Incision', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Type of Uterine Incision', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Type of Fascia Closure', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Type of Subcutaneous Closure', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}, {'measure': 'Administration of Preoperative Antibiotics', 'timeFrame': 'At the time of cesarean delivery', 'description': 'Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other'}, {'measure': 'Quantitative Blood Loss', 'timeFrame': 'At the time of cesarean delivery', 'description': 'We were unable to adequately recruit for this study. Study was closed.'}], 'primaryOutcomes': [{'measure': 'Composite Wound Complication', 'timeFrame': 'Four weeks postpartum', 'description': 'Any of wound infection, seroma/hematoma, wound separation \\>1 cm, and wound dehiscence'}], 'secondaryOutcomes': [{'measure': 'Patient Survey', 'timeFrame': 'Four weeks postpartum', 'description': "Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obesity, Morbid', 'Wound Infection', 'Wound Complication']}, 'descriptionModule': {'briefSummary': 'Obese women are more likely have a cesarean delivery and develop subsequent wound complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown to improve surgical wound healing, but this device has not been adequately studied in cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly obese women after cesarean delivery.\n\nInvestigators will be randomizing women with a BMI \\> 40 kg/m2 in a 1:1 ratio to either NPWT (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a minimum of four days but not to exceed seven days. The standard dressing is typically removed on postoperative day one or two. The primary outcome is a wound complication defined as the formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to 4 weeks postpartum. Investigators will also administer a patient satisfaction survey regarding their wound healing experience.', 'detailedDescription': 'Obese women are more likely to be delivered by cesarean than normal weight women and are at increased risk for operative morbidity including wound complications. Negative pressure wound therapy (NPWT) has been shown to improve wound healing, decrease the rate of surgical site infection, sero-hematoma formation, and reoperation rates. The potential benefit of NPWT in high-risk wounds after cesarean delivery is unclear. Investigators propose conducting a single-site randomized controlled trial to examine the efficacy of NPWT after cesarean delivery in morbidly obese women (BMI ≥ 40 kg/m2).\n\nSpecific aims of the study include determining if NPWT used in morbidly obese women after cesarean delivery improves postoperative wound complication rate and to assess patient satisfaction with NPWT. The primary outcome is a composite wound complication rate defined as having one of the following occur within four weeks of delivery: wound infection, seroma, hematoma, separation, or dehiscence.\n\nParticipants will be randomized in a 1:1 ratio to either NPWT or standard surgical dressing. Women receiving NWPT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery. Women randomized to the standard surgical dressing will have a TELFA non-adhesive dressing with a 3M Tegaderm transparent film adhesive dressing. In addition, an abdominal pad (ABD) with foam tape may be applied to provide additional pressure if needed.\n\nThe wound will be assessed at the time of dressing removal or hospital discharge and at four weeks postoperative. Participants will also take a patient satisfaction survey regarding wound healing experience at four-week follow-up. For the study, investigators are planning to enroll 482 patients (241 per arm) to demonstrate a decrease in the wound complication rate by 50%. This study will help clinicians better manage obese women in pregnancy and hopefully improve wound outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index ≥40 kg/m2 at time of delivery\n* Delivered by cesarean delivery\n* 18 years or later\n\nExclusion Criteria:\n\n* Chorioamnionitis\n* Silver allergy\n* Inability to follow up'}, 'identificationModule': {'nctId': 'NCT03269968', 'briefTitle': 'Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery', 'orgStudyIdInfo': {'id': '2017-137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Negative pressure wound therapy (NPWT)', 'description': 'Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.', 'interventionNames': ['Device: Negative pressure wound therapy (PREVENA Incision Management Therapy System)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard dressing', 'description': 'Standard dressing', 'interventionNames': ['Device: Standard dressing']}], 'interventions': [{'name': 'Negative pressure wound therapy (PREVENA Incision Management Therapy System)', 'type': 'DEVICE', 'description': 'After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.', 'armGroupLabels': ['Negative pressure wound therapy (NPWT)']}, {'name': 'Standard dressing', 'type': 'DEVICE', 'description': 'After cesarean delivery, women in the intervention group will receive standard dressing.', 'armGroupLabels': ['Standard dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Rachael T Overcash, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}, {'name': 'Iqbal N Iqbal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amenity Health, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}