Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT03222102
Status:
TERMINATED
Last Update Posted:
2025-01-27
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventral Hernia Prevention After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Due to the changed standard regarding access for liver transplantation, this no longer complied with the requirements of the study protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ventral hernia', 'timeFrame': '12 months after liver transplantation', 'description': 'Evaluated by ultra-sound imaging'}], 'secondaryOutcomes': [{'measure': 'Infections', 'timeFrame': '12 months after liver transplantation', 'description': 'Number of infections in the wound area, assessed by clinical evaluation'}, {'measure': 'Wound healing disorders', 'timeFrame': '12 months after liver transplantation', 'description': 'Presence of wound healing disorders in the wound area, assessed by clinical evaluation'}, {'measure': 'Seroma', 'timeFrame': '12 months after liver transplantation', 'description': 'Presence of seroma in the wound area, assessed by clinical evaluation'}, {'measure': 'Hematoma', 'timeFrame': '12 months after liver transplantation', 'description': 'Number of hematoma in the wound area, assessed by clinical evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventral Hernia', 'Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.\n\nPatients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.\n\nUltra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.', 'detailedDescription': 'Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.\n\nThis study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.\n\nPHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.\n\nPatients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.\n\nUltra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* First transplantation\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Combined transplantation\n* Revisions after liver transplantation\n* Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)\n* Preexisting abdominal wall hernia except umbilical hernia after liver transplantation\n* Pregnant/lactating women\n* Known allergies to tetracycline hydrochloride and kanamycin sulfate'}, 'identificationModule': {'nctId': 'NCT03222102', 'briefTitle': 'Ventral Hernia Prevention After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Ventral Hernia Prevention After Liver Transplantation', 'orgStudyIdInfo': {'id': 'Ventral hernia prevention'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phasix mesh', 'description': 'Phasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation.', 'interventionNames': ['Device: Phasix mesh']}, {'type': 'NO_INTERVENTION', 'label': 'Standard surgery', 'description': 'Surgery will be performed according to routine, without the use of Phasix mesh.'}], 'interventions': [{'name': 'Phasix mesh', 'type': 'DEVICE', 'description': 'After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.', 'armGroupLabels': ['Phasix mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz; Klin. Abteilung für Transplantationschirurgie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}