Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 2:27 PM
Study NCT ID:
NCT01528033
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2012-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Netherlands', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'Doerthe.Seidel@uni-wh.de', 'phone': '00492219895731', 'title': 'Dörthe Seidel', 'organization': 'Witten/Herdecke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs)', 'description': 'Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'NPWT', 'description': 'Negative Pressure Wound Therapy', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 256, 'otherNumAffected': 41, 'seriousNumAtRisk': 234, 'deathsNumAffected': 24, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'SCWT', 'description': 'Standard Conventional Wound Treatment', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 251, 'otherNumAffected': 22, 'seriousNumAtRisk': 201, 'deathsNumAffected': 15, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Adverse Device Events (NPWT-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conventional Wound Treatment - related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 51, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Adverse Device Events (NPWT-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conventional Wound Treatment-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete Wound Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NPWT', 'description': 'Negative Pressure Wound Therapy'}, {'id': 'OG001', 'title': 'SCWT', 'description': 'Standard Conventional Wound Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': '37.2'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '40.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days', 'description': 'Time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days (14 days -0 / + 3)\n\nComplete wound closure is defined as:\n\n100% epithelialization No drainage from the wound No need for adjuvant therapy or dressing No presence of sutures', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat Population'}, {'type': 'SECONDARY', 'title': 'Incidence of Confirmed and Verified Wound Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NPWT', 'description': 'Negative Pressure Wound Therapy'}, {'id': 'OG001', 'title': 'SCWT', 'description': 'Standard Conventional Wound Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat Population'}, {'type': 'SECONDARY', 'title': 'Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NPWT', 'description': 'Negative Pressure Wound Therapy'}, {'id': 'OG001', 'title': 'SCWT', 'description': 'Standard Conventional Wound Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '132 days', 'description': 'Recurrence of wound opening after confirmed wound closure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vacuum Assisted Closure®', 'description': 'Negative pressure wound therapy\n\nVacuum Assisted Closure®: Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days.\n\nVAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the study site.\n\nSystems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.'}, {'id': 'FG001', 'title': 'Standard Conventional Wound Therapy', 'description': 'According to institutional clinical standards\n\nStandard conventional wound therapy: Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days'}], 'periods': [{'title': 'Primary Endpoint Assessment ITT', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '266'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'No or deliquent informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No post baseline documentation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'No data available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}], 'recruitmentDetails': 'Patients were enrolled betweenAugust 2, 2011, and January 31, 2018 in 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NPWT', 'description': 'Negative Pressure Wound Therapy'}, {'id': 'BG001', 'title': 'SCWT', 'description': 'Standard Conventional Wound Treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '13', 'groupId': 'BG000'}, {'value': '64', 'spread': '14', 'groupId': 'BG001'}, {'value': '64', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '486', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '86', 'spread': '19', 'groupId': 'BG000'}, {'value': '84', 'spread': '21', 'groupId': 'BG001'}, {'value': '85', 'spread': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '172', 'spread': '11', 'groupId': 'BG000'}, {'value': '169', 'spread': '11', 'groupId': 'BG001'}, {'value': '171', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.71', 'spread': '8.58', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only for those patientes with information available'}, {'title': 'Drug use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nutritional status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Well nourished', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}, {'title': 'Moderately or suspected of being malnourished', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Severely malnourished', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Wound volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=60 cm*3', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}, {'title': '>60 cm*3', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only for those patients with available Information'}, {'title': 'Coagulation: Prothrombin Time (PT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88.3', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '88.3', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '88.3', 'spread': '17.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage (%)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Laboratory values are only available for patients with blood samples collected within clinical routine'}, {'title': 'Coagulation: International Normalized Ratio (INR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Laboratory values are only available for patients with blood samples collected within clinical routine'}, {'title': 'Coagulation: Partial Thromboplastin Time (pTT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds (s)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Laboratory values are only available for patients with blood samples collected within clinical routine'}, {'title': 'Diagnosis of abdominal wound healing disorder', 'classes': [{'title': 'Spontaneous dehiscence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Active reopening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}]}, {'title': 'Wound left open after surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical signs of infection during screening', 'classes': [{'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}, {'title': 'Not assesable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only for those patients with Information available'}, {'title': 'Leven of surgical site infection according to CDC classification at Screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Superficial incisional', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Deep incisional', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Organ or space infection', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)'}, {'title': 'Clinical signs of local infection at randomization,', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Not assessable', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients with documentation availabe at Randomization = 247'}, {'title': 'Level of surgical site infection according to CDC classification at Randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Superficial incisional', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Deep incisional', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Organ or space infection', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)'}, {'title': 'Main procedure that caused the abdominal wound healing impairment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Incision, excision, resection and anastomose of th', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'Other operations on the small and large intestine', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Appendix surgery', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Rectal surgery', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Anal surgery', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Esophagus surgery', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Gastric incision, excision, and resection', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Extended gastric resection and other gastric surge', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Liver surgery', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Gall bladder and bile ducts surgery', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Pancreatic surgery', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Closure of abdominal hernias', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Operations on other abdominal regions', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only for those patients with documentation available (NPWT=255; SCWT=248)'}], 'populationDescription': 'Intention To Treat Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-09-17', 'size': 1282117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-28T11:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 539}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2012-02-02', 'resultsFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-24', 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete Wound Closure', 'timeFrame': '42 days', 'description': 'Time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days (14 days -0 / + 3)\n\nComplete wound closure is defined as:\n\n100% epithelialization No drainage from the wound No need for adjuvant therapy or dressing No presence of sutures'}], 'secondaryOutcomes': [{'measure': 'Incidence of Confirmed and Verified Wound Closure', 'timeFrame': '42 days', 'description': 'Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)'}, {'measure': 'Recurrence', 'timeFrame': '132 days', 'description': 'Recurrence of wound opening after confirmed wound closure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['surgical wound', 'wound healing disorder', 'Wound healing impairment', 'post surgical wound healing disorder', 'abdominal wound healing impairment', 'Vacuum Assisted Closure', 'negative pressure wound therapy'], 'conditions': ['Wound Healing Disorder', 'Impaired Wound Healing', 'Abdominal Wound Healing Disorder', 'Abdominal Wound Healing Impairment', 'Acute Postsurgical Subcutaneous Wound']}, 'referencesModule': {'references': [{'pmid': '24252551', 'type': 'BACKGROUND', 'citation': 'Seidel D, Lefering R, Neugebauer EA. Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure (SAWHI-V.A.C.(R)-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial. Trials. 2013 Nov 20;14:394. doi: 10.1186/1745-6215-14-394.'}, {'pmid': '32293657', 'type': 'RESULT', 'citation': 'Seidel D, Diedrich S, Herrle F, Thielemann H, Marusch F, Schirren R, Talaulicar R, Gehrig T, Lehwald-Tywuschik N, Glanemann M, Bunse J, Huttemann M, Braumann C, Heizmann O, Miserez M, Kronert T, Gretschel S, Lefering R. Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial. JAMA Surg. 2020 Jun 1;155(6):469-478. doi: 10.1001/jamasurg.2020.0414.'}, {'pmid': '36503505', 'type': 'DERIVED', 'citation': 'Seidel D; SAWHI study group. Ambulatory negative pressure wound therapy of subcutaneous abdominal wounds after surgery: results of the SAWHI randomized clinical trial. BMC Surg. 2022 Dec 12;22(1):425. doi: 10.1186/s12893-022-01863-x.'}], 'seeAlsoLinks': [{'url': 'http://www.uni-wh.de', 'label': 'Sponsor'}]}, 'descriptionModule': {'briefSummary': 'This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact.\n\nMain outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters.\n\nPatients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm.\n\nThe primary outcome measure and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation.\n\nPatients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure.\n\nStudy participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project.\n\nTrial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.', 'detailedDescription': "The Institute for Research in Operative Medicine as part of the Private University of Witten /Herdecke is planning and performing a clinical trial project to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) Therapy for the treatment of postsurgical abdominal wound healing impairments after surgery without fascial dehiscence. The clinical trial project is fully financed by Kinetic Concepts Incorporated (KCI). The V.A.C.® Therapy devices that will be used in this study include the ActiV.A.C.® Therapy System, InfoV.A.C.® Therapy System, and V.A.C. Freedom® Therapy System. All V.A.C.® Therapy devices to be utilized in this study bear the CE mark and will be operated within normal conditions of use and according to manufacturer's specifications.\n\nBackground of the clinical trial project is the decision of the Joint Federal Committee of Germany (Gemeinsamer Bundesausschusses (G-BA)) that Vacuum assisted closure therapy is inadmissible to be a standard benefit of health insurance companies in Germany.\n\nThis decision is based on systematic review \\& meta-analysis of existing trials performed by Institute for Quality and Economic Efficiency in the Healthcare System (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)) which showed an insufficient state of evidence regarding the efficacy of negative pressure wound therapy for the treatment of acute and chronic wounds.\n\nThis study project compares Vacuum Assisted Closure® and standard conventional wound therapy in the treatment of acute abdominal wounds after surgery without fascial dehiscence and will be conducted in abdominal surgical hospital departments with the required structural, manpower, and scientific qualifications. Patients will be stratified according to hospital and wound size. Trial therapy will be started in-hospital and may be continued in ambulatory care.\n\nThe study is designed as a multinational, multicentre, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint.\n\nThe primary objective is to compare the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT in postsurgical abdominal wound healing impairments without fascial dehiscence.\n\nThe primary outcome to be observed in this study is time to complete abdominal wound closure where closure is observed at or before day 42 and is confirmed to have been sustained for a period of at least 14 consecutive days. This study design also will allow detailed description of specific covariates to determine their effect on response variables (healing).\n\nThis study's hypothesis is that the use of the V.A.C.® Therapy System, when compared to SCWT in the management of post-surgical abdominal wound healing impairments with intact fascia, will result in a decrease in the time to achieve complete wound closure with confirmation after subsequent 14 days.\n\nUsing V.A.C.® Therapy is an effective and safe treatment option for hospitals as well as for outpatient care for treatment of subcutaneous abdominal wounds with wound healing impairment in the postoperative course.\n\nRandomisation to treatment arms will be performed at a 1:1 ratio. Randomisation will be performed via a centralized system with an Internet-based tool. To address issues of blinding, wound photo documentation will be obtained during the trial and confirmation of wound closure will be assessed via blinded photographic analysis, which will serve as the method of primary endpoint analysis.\n\nPrimary closed abdominal wounds with wound healing disorder in the postoperative course after surgical intervention without fascial dehiscence are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure.\n\nDuring active recruitment phase, the pre-trial estimates indicate approximately 600 patients will be required to yield the target of 552 evaluable participants. Using an adaptive design study sample-size calculations will be re-estimated upon planed interim analysis of study data of 250 patients. Patients will be enrolled from approximately 25 centres in Germany, the United Kingdom, Belgium and the Netherlands.\n\nThe evaluation of the primary Endpoint defined as time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days and secondary endpoints including clinical endpoints like recurrences, safety endpoints, patient reported outcome parameters and economic-based outcome measures will provide data regarding efficacy and efficiency of NPWT therapy for the treatment of acute post-surgical abdominal wound healing impairment in hospital as well as in the ambulant setting.\n\nThe results of the study will be provided to make a contribution to the final decision of the Joint Federal Committee about NPWT to be a standard benefit of health insurance companies in Germany for inpatient and / or outpatient care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Post-surgical subcutaneous abdominal wound healing impairment\n* Minimum wound size eligible for the application of the randomized treatment- Inclusion, randomization, adequate wound pre-treatment (Debridement) and start of therapy within 48 hours after reopening of the wound, diagnosis for nonclosable wound or in case of spontaneous wound dehiscence\n\nExclusion Criteria:\n\n* Age \\< 18\n* Noncompliance with study procedures, visit schedule and follow up\n* Pregnancy\n* Present or nonclosable defect of the abdominal fascia\n* Any pre-existing or ongoing organ system failure, that cannot be stabilized or solved by appropriate medical treatment\n* Necrotic tissue with eschar present\n* Non-enteric and unexplored fistulas\n* Malignancy of the wound\n* Use of any other device based on the principle of negative pressure wound therapy on the study wound within ≤ 8 days prior to screening\n* Competing therapies or procedures\n* Simultaneous participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT01528033', 'acronym': 'SAWHI', 'briefTitle': 'Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments', 'organization': {'class': 'OTHER', 'fullName': 'University of Witten/Herdecke'}, 'officialTitle': 'Treatment of Subcutaneous Abdominal Wound Healing Impairment After Surgery Without Fascial Dehiscence by Vacuum Assisted Closure™(SAWHI-V.A.C.® Study) Versus Standard Conventional Wound Therapy', 'orgStudyIdInfo': {'id': 'VAC2010-56'}, 'secondaryIdInfos': [{'id': '00000648', 'type': 'REGISTRY', 'domain': 'DRKS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vacuum Assisted Closure®', 'description': 'Negative pressure wound therapy', 'interventionNames': ['Device: Vacuum Assisted Closure®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard conventional wound therapy', 'description': 'According to institutional clinical standards', 'interventionNames': ['Other: Standard conventional wound therapy']}], 'interventions': [{'name': 'Vacuum Assisted Closure®', 'type': 'DEVICE', 'otherNames': ['Negative Pressure Wound Therapy'], 'description': 'Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days.\n\nVAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the trial site.\n\nSystems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.', 'armGroupLabels': ['Vacuum Assisted Closure®']}, {'name': 'Standard conventional wound therapy', 'type': 'OTHER', 'description': 'Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days', 'armGroupLabels': ['Standard conventional wound therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Department of Abdominal Surgery Gasthuisberg University Hospital', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10365', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Sana Klinikum Lichtenberg (Berlin)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'St. Josef-Hospital gGmbH Universitätsklinikum der Ruhr-Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes, Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '16816', 'city': 'Neuruppin', 'country': 'Germany', 'facility': 'Ruppiner Kliniken GmbH', 'geoPoint': {'lat': 52.92815, 'lon': 12.80311}}, {'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Klinikum Ernst von Bergmann, Klinik für Allgemein- und Visceralchirurgie', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '27356', 'city': 'Rotenburg (Wümme)', 'country': 'Germany', 'facility': 'Diakoniekrankenhaus Rotenburg', 'geoPoint': {'lat': 53.11032, 'lon': 9.4036}}, {'zip': '07318', 'city': 'Saalfeld', 'country': 'Germany', 'facility': 'Thüringen-Kliniken "Georgius Agricola" GmbH', 'geoPoint': {'lat': 50.64826, 'lon': 11.36536}}, {'zip': '74889', 'city': 'Sinsheim', 'country': 'Germany', 'facility': 'GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie', 'geoPoint': {'lat': 49.2529, 'lon': 8.87867}}], 'overallOfficials': [{'name': 'Doerthe Seidel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Witten / Herdecke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCI Europe Holding B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interim Scientific Leader of the Centre for Clinical Trials and Innovation', 'investigatorFullName': 'Doerthe Seidel', 'investigatorAffiliation': 'University of Witten/Herdecke'}}}}