Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-03-27 @ 8:32 AM
Study NCT ID:
NCT00754156
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2008-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ABRA Abdominal Closure System in Open Abdomen Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arockich@uky.edu', 'phone': '859-323-6346', 'title': 'Phillip Chang, M.D. PI or Anna Rockich, Pharm.D. GSRP Director', 'phoneExt': '247', 'organization': 'University of Kentucky Medical Center'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '1. Limited by small sample size, and lack of closely matched patient groups.\n2. Limited by product change from the original VAC to the ABThera system mid study.\n3. Limited by a significant learning curve in application and use of the ABRA device.'}}, 'adverseEventsModule': {'timeFrame': 'Hospitalization of enrollment', 'eventGroups': [{'id': 'EG000', 'title': '1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'ABThera V.A.C. Therapy alone', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Enterocutaneous Fistula', 'notes': 'This patient developed an entercutaneous fistula during her involvement with the study. She recovered without issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Device failure and skin breakdown', 'notes': 'Mass amount of drainage and infection and absence of wound edge for \\> 3 days required ABRA removal. Following removal 2 JP drains and wound vac was required. Soft tissue debridement was needed where the ABR button pads rested.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Closure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 ABThera', 'description': 'ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 months', 'description': 'The rate in which the abdomen was closed the first time.', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive Study.'}, {'type': 'PRIMARY', 'title': 'Number of Trips to the Operating Room', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with V.A.C or ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 ABThera', 'description': 'V.A.C. or ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Months', 'unitOfMeasure': 'Number of trips', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Operating Room Time Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus V.A.C. or ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with V.A.C. or ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'V.A.C. or ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '29', 'groupId': 'OG000'}, {'value': '212', 'spread': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalence analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Duration of Hospital Stay less than 6 months', 'description': 'The amount of time needed to manage the open abdomen inside the operating room.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days to Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '18.0'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '5.56', 'upperLimit': '10.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of Hospital Stay less than 6 months', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '55.0'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '23.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of hospital stay less than 6 months', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '60.8'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '31.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of Hospital Stay less than 6 months', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy'}, {'id': 'OG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'ABThera V.A.C. Therapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': '2650', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7493'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '758'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of Hospital Stay less than 6 months', 'unitOfMeasure': 'Units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy'}, {'id': 'FG001', 'title': '2 V.A.C. or ABThera Alone', 'description': 'ABThera V.A.C. Therapy alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients who met study criteria were enrolled from January 26, 2009 through December 6, 2010.', 'preAssignmentDetails': 'Study candidates were identified following index laparotomy where the abdominal cavity could not be closed primarily. Following informed consent, patients were enrolled if attempts at primary closure were unsuccessful during the second laparotomy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 ABRA Plus V.A.C or ABThera', 'description': 'ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy'}, {'id': 'BG001', 'title': 'V.A.C. or ABThera', 'description': 'V.A.C. or ABThera Therapy alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '51.14', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '38.0', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '30.99', 'spread': '2.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Base Excess/Base Deficit', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '2.5-18.1', 'groupId': 'BG000', 'lowerLimit': '-4.9', 'upperLimit': '19.8'}, {'value': '5.1', 'spread': '0.5-9.8', 'groupId': 'BG001', 'lowerLimit': '-2.4', 'upperLimit': '15'}, {'value': '5.9', 'groupId': 'BG002', 'lowerLimit': '-4.9', 'upperLimit': '19.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'In human physiology, base excess and base deficit refer to an excess or deficit, respectively, in the amount of base present in the blood. The value is usually reported as a concentration in units mmol/L, with a positive number indicating excess of base and a negative deficit. A range for base excess or base deficit is -3 to + 3 mmol/L', 'unitOfMeasure': 'mmole/liter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'APACHE II', 'classes': [{'categories': [{'measurements': [{'value': '21.25', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '16', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '19.00', 'spread': '2.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'APACHE II (Acute Physiology and Chronic Health Evaluation) scoring system is an objective assessment of severity of illness in patients in the ICU. Scores can range from 0 (low severity) to 71 (high severity).', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Starting Wound Dimension', 'classes': [{'categories': [{'measurements': [{'value': '575.9', 'spread': '289.2', 'groupId': 'BG000'}, {'value': '359.2', 'spread': '245.3', 'groupId': 'BG001'}, {'value': '483', 'spread': '75.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Trauma', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients that are trauma patients', 'unitOfMeasure': 'participants'}, {'title': 'Vascular/Splenectomy/AAA', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients who met criteria for entry who had baseline conditions to include vascular issue or splenectomy', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2008-09-16', 'resultsFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2008-09-16', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-15', 'studyFirstPostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Closure Rate', 'timeFrame': 'up to 12 months', 'description': 'The rate in which the abdomen was closed the first time.'}, {'measure': 'Number of Trips to the Operating Room', 'timeFrame': '12 Months'}, {'measure': 'Operating Room Time Utilization', 'timeFrame': 'Duration of Hospital Stay less than 6 months', 'description': 'The amount of time needed to manage the open abdomen inside the operating room.'}], 'secondaryOutcomes': [{'measure': 'Days to Closure', 'timeFrame': 'Duration of Hospital Stay less than 6 months'}, {'measure': 'ICU Days', 'timeFrame': 'Duration of hospital stay less than 6 months'}, {'measure': 'Hospital Days', 'timeFrame': 'Duration of Hospital Stay less than 6 months'}, {'measure': 'Blood Transfused', 'timeFrame': 'Duration of Hospital Stay less than 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Closure, Wounds'], 'conditions': ['Open Abdomen']}, 'descriptionModule': {'briefSummary': 'For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal compartment syndrome, and critically ill surgical patients with profound acidosis. While these advances have saved lives, they have also led to a dramatic increase in patients with open abdominal cavities. Various methods have been employed to offer protection to the viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch , and the use of vacuum assisted fascia-closure, including the commercially available system offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an average of 10 days. Unfortunately, there has been no well-designed comparison study available. Some of the best results also require returning to the operating room every 3 to 5 days.\n\nAt the University of Kentucky Medical Center, a combination of the vacuum pack dressing described by Barker, the commercially available VAC system (V.A.C.; KCI International, San Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is approximately 50%. It is not standard practice to take patients to the OR every 3-5 days routinely.\n\nRecently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic reduction of full thickness, severely retracted midline abdominal defects with the goal of maintaining or restoring the primary closure option. This subdermal method uses button anchors and elastomer to gradually pull the wound margins together. Tension can be set and adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound, close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there is only one published case report of the success of this device. We hope to be the first center to prospectively report a series of patients with open abdomen managed with the new ABRA system. In this study, this system will be used in combination with a standard therapy used in abdominal wound closure at the University of Kentucky Medical Center. This system is called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides active exudate management and containment, assists in reducing abdominal volume and adds structural stabilization to adipose tissue.\n\nAlthough no highly powered study has been done to establish data on performance, individual experiences at several institutions have reached fascial closure rates of higher than 70% using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in combination with the VAC system and has experienced 100% closure rate to date with 12 patients. The purpose of this study is to collect information about the ABRA system in combination with the VAC technique at the University of Kentucky Medical Center. It is our belief that using this system will improve the fascial closure rate and thereby produce less chance of hernia and reduce long periods of open abdominal wounds. The objective of the study is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system combined with the K.C.I. VAC System to KCI VAC System alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ages of 18 and 70\n2. patients deemed not a candidate for primary fascial closure at the second laparotomy.\n\nExclusion Criteria:\n\n1. High risk for imminent death, as determined by the attending surgeon and PI\n2. Pre-existing large ventral hernia\n3. Significant loss of abdominal wall fascia as a result of trauma or infection\n4. Known Crohn's disease\n5. Pregnancy"}, 'identificationModule': {'nctId': 'NCT00754156', 'acronym': 'ABRA', 'briefTitle': 'ABRA Abdominal Closure System in Open Abdomen Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'A Prospective, Controlled Evaluation of ABRA Abdominal Wall Closure System in Combination With V.A.C. Therapy Compared to V.A.C. Alone in the Management of Open Abdomen', 'orgStudyIdInfo': {'id': '07-0694-F2L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 ABRA plus KCI ABThera or KCI VAC', 'description': 'ABRA Abdominal Wound Closure System in combination with KCI ABThera or KCI VAC', 'interventionNames': ['Device: V.A.C. Therapy', 'Device: KCI ABThera']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KCI V.A.C. Therapy or ABThera Alone', 'description': 'KCI V.A.C. Therapy ABThera Alone', 'interventionNames': ['Device: ABRA Abdominal Closure System', 'Device: V.A.C. Therapy', 'Device: KCI ABThera']}], 'interventions': [{'name': 'ABRA Abdominal Closure System', 'type': 'DEVICE', 'description': 'ABRA Abdominal Closure System', 'armGroupLabels': ['KCI V.A.C. Therapy or ABThera Alone']}, {'name': 'V.A.C. Therapy', 'type': 'DEVICE', 'description': 'V.A.C. Therapy Alone', 'armGroupLabels': ['1 ABRA plus KCI ABThera or KCI VAC', 'KCI V.A.C. Therapy or ABThera Alone']}, {'name': 'KCI ABThera', 'type': 'DEVICE', 'description': 'KCI ABThera', 'armGroupLabels': ['1 ABRA plus KCI ABThera or KCI VAC', 'KCI V.A.C. Therapy or ABThera Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Phillip Chang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Rockich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, General Surgery Clinical Research Program', 'investigatorFullName': 'Anna Rockich', 'investigatorAffiliation': 'University of Kentucky'}}}}