Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT01649505
Status:
TERMINATED
Last Update Posted:
2022-11-02
First Post:
2012-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D016462', 'term': 'Mammaplasty'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hansenju@ohsu.edu', 'phone': '503-494-4834', 'title': 'Dr. Juliana Hansen', 'organization': 'Oregon Health and Science University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Data was not collected due to early termination and very low accrual.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients in Each Arm Who Develop Post-operative Seromas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.\n\nbreast reconstruction : Undergo sharp dissection technique\n\nfibrin sealant (Beriplast P, TISSEEL VH) : Applied topically'}, {'id': 'OG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.\n\nbreast reconstruction : Undergo electrocoagulation dissection technique'}], 'timeFrame': 'Up to day 180 post-operation', 'description': "Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected due to early termination and very low accrual'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.\n\nfibrin sealant (Beriplast P, TISSEEL VH): Applied topically\n\nbreast reconstruction: Undergo sharp dissection technique'}, {'id': 'OG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.\n\nbreast reconstruction: Undergo electrocoagulation dissection technique'}], 'timeFrame': 'Up to day 180 post-operation', 'description': "Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected due to early termination and very low accrual'}, {'type': 'SECONDARY', 'title': 'Quantity of Post-operative Drainage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.\n\nbreast reconstruction : Undergo sharp dissection technique\n\nfibrin sealant (Beriplast P, TISSEEL VH) : Applied topically'}, {'id': 'OG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.\n\nbreast reconstruction : Undergo electrocoagulation dissection technique'}], 'timeFrame': 'Up to day 10 post-operation', 'description': 'Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected due to early termination and very low accrual'}, {'type': 'SECONDARY', 'title': 'Serious and Nonserious Adverse Events and Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.\n\nbreast reconstruction : Undergo sharp dissection technique\n\nfibrin sealant (Beriplast P, TISSEEL VH) : Applied topically'}, {'id': 'OG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.\n\nbreast reconstruction : Undergo electrocoagulation dissection technique'}], 'timeFrame': 'Up to day 180 post-operation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected due to early termination and very low accrual'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.\n\nbreast reconstruction : Undergo sharp dissection technique\n\nfibrin sealant (Beriplast P, TISSEEL VH) : Applied topically'}, {'id': 'FG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.\n\nbreast reconstruction : Undergo electrocoagulation dissection technique'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Fibrin Sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.\n\nbreast reconstruction : Undergo sharp dissection technique\n\nfibrin sealant (Beriplast P, TISSEEL VH) : Applied topically'}, {'id': 'BG001', 'title': 'Arm II (Standard Electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.\n\nbreast reconstruction : Undergo electrocoagulation dissection technique'}, {'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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low patient enrollment and no clinical findings.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2012-07-20', 'resultsFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-03-13', 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients in Each Arm Who Develop Post-operative Seromas', 'timeFrame': 'Up to day 180 post-operation', 'description': "Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups."}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications', 'timeFrame': 'Up to day 180 post-operation', 'description': "Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed."}, {'measure': 'Quantity of Post-operative Drainage', 'timeFrame': 'Up to day 10 post-operation', 'description': 'Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.'}, {'measure': 'Serious and Nonserious Adverse Events and Complications', 'timeFrame': 'Up to day 180 post-operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Perioperative/Postoperative Complications']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients undergo sharp dissection technique with fibrin sealant closure.\n\nARM II: Patients undergo standard electrocoagulation dissection technique.\n\nAfter completion of study treatment, patients are followed up for 90-180 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU)\n* These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant\n* Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery'}, 'identificationModule': {'nctId': 'NCT01649505', 'briefTitle': 'Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas', 'orgStudyIdInfo': {'id': 'IRB00006606'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00809', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (fibrin sealant)', 'description': 'Patients undergo sharp dissection technique with fibrin sealant closure.', 'interventionNames': ['Drug: fibrin sealant (Beriplast P, TISSEEL VH)', 'Procedure: breast reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (standard electrocoagulation)', 'description': 'Patients undergo standard electrocoagulation dissection technique.', 'interventionNames': ['Procedure: breast reconstruction']}], 'interventions': [{'name': 'fibrin sealant (Beriplast P, TISSEEL VH)', 'type': 'DRUG', 'otherNames': ['Beriplast P', 'TISSEEL VH'], 'description': 'Applied topically', 'armGroupLabels': ['Arm I (fibrin sealant)']}, {'name': 'breast reconstruction', 'type': 'PROCEDURE', 'otherNames': ['Mammaplasty'], 'description': 'Undergo sharp dissection technique', 'armGroupLabels': ['Arm I (fibrin sealant)']}, {'name': 'breast reconstruction', 'type': 'PROCEDURE', 'otherNames': ['Mammaplasty'], 'description': 'Undergo electrocoagulation dissection technique', 'armGroupLabels': ['Arm II (standard electrocoagulation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Juliana Hansen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juliana Hansen', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}