Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-03 @ 3:31 AM
Study NCT ID:
NCT02612220
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2015-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2015-11-20', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-complete hemostasis', 'timeFrame': '3 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver resection'], 'conditions': ['Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '31680010', 'type': 'DERIVED', 'citation': 'Rahbari NN, Birgin E, Sturm D, Schwanebeck U, Weitz J, Reissfelder C. Randomized clinical trial of BioFoam(R) Surgical Matrix to achieve hemostasis after liver resection. HPB (Oxford). 2020 Jul;22(7):987-995. doi: 10.1016/j.hpb.2019.10.1529. Epub 2019 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'The present randomized controlled trial evaluates the efficacy and safety of BioFoam® Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications.\n\nThe primary objective of this trial is to show that time-to-complete hemostasis can be reduced using BioFoam® Surgical Matrix as compared to the conventional approach.', 'detailedDescription': "Hepatic resection is the primary therapy for various hepatobiliary disorders. Advances in preoperative imaging, surgical technique, and perioperative management have markedly improved outcomes and extended the indications for hepatic resection within the past three decades. However, liver resection remains associated with substantial morbidity and mortality of up to 60% and 10%, respectively. The outcome of patients undergoing hepatic resection is closely linked to the amount of intraoperative blood loss. Hemorrhage from the resection surface contributes significantly to the amount of blood loss. In addition, bile leakage from the resection surface presents a persistent clinical challenge. In fact, bile leakage remains the most frequent complication after hepatic resection with an incidence of 5 - 25%. Various topical agents have so far been suggested to facilitate hemostasis with the ultimate aim to improve perioperative outcome. However, none of these agents has so far gained wide acceptance, possibly due to their impractical method of application. Furthermore, these 'hemostatic agents' have been primarily designed to improve hemostasis and showed no effect on perioperative complications and in particular the incidence of bile leakage.\n\nThe present randomized controlled trial evaluates the efficacy and safety of BioFoam® Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective hepatic resection\n* Age equal or greater than 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* Previous treatment with BioFoam® Surgical Matrix\n* Known sensitivity to materials of bovine origin\n* Known sensitivity to glutaraldehyde\n* Abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyreoidism)\n* Minimally invasive procedure planned\n* Impaired mental state or language problems\n* Expected lack of compliance'}, 'identificationModule': {'nctId': 'NCT02612220', 'acronym': 'BioFoam', 'briefTitle': 'Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VTG-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Complete hemostasis will be achieved using BioFoam® Surgical Matrix', 'interventionNames': ['Procedure: BioFoam® Surgical Matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Complete hemostasis will be achieved without the use of topical agents, using conservative hemostasis', 'interventionNames': ['Other: Conservative hemostasis']}], 'interventions': [{'name': 'BioFoam® Surgical Matrix', 'type': 'PROCEDURE', 'description': "Complete hemostasis is achieved by direct application of BioFoam® (Cryolife Inc., Kennesaw, GA) to the transection surface area of the liver. In addition, the surgeon may use conventional methods such as argon beam coagulation and warm sponges. If more than one syringe of BioFoam® is required to cover the entire transection surface area, a second syringe maybe used. BioFoam® Surgical Matrix will be used according to the supplier's instructions.", 'armGroupLabels': ['Experimental Group']}, {'name': 'Conservative hemostasis', 'type': 'OTHER', 'description': 'Complete hemostasis will be achieved without the use of topical agents', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Christoph Reißfelder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'CryoLife, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}