Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-05-29 @ 10:13 AM
Study NCT ID:
NCT03064893
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-17', 'releaseDate': '2025-04-01'}, {'resetDate': '2025-07-10', 'releaseDate': '2025-06-23'}, {'resetDate': '2025-12-02', 'releaseDate': '2025-11-19'}, {'releaseDate': '2025-12-12'}], 'estimatedResultsFirstSubmitDate': '2025-04-01'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative duration of drain placements', 'timeFrame': 'within 6 months of initial surgery'}], 'secondaryOutcomes': [{'measure': 'Episodes of seroma formation requiring aspiration', 'timeFrame': 'within 6 months of initial surgery'}, {'measure': 'Loss of implant', 'timeFrame': 'within 6 months of initial surgery'}, {'measure': 'Revisional surgery/ return to operating room', 'timeFrame': 'within 6 months of initial surgery'}, {'measure': 'Wound dehiscence or debridement', 'timeFrame': 'within 6 months of initial surgery'}, {'measure': 'Capsular contracture (as identified by the plastic surgeon)', 'timeFrame': 'within 6 months of initial surgery'}, {'measure': 'Number of additional postoperative clinic visits with the plastic surgeon (beyond the routine)', 'timeFrame': 'within 6 months of initial surgery'}, {'measure': 'Economics of total costs', 'timeFrame': '2 years', 'description': 'Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient\n* Ages 20-90\n* All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction\n* Able to provide verbal consent\n\nExclusion Criteria:\n\n* Patients who have had prior chest wall or irradiation on the reconstructed side\n* Patients not undergoing immediate breast reconstruction at the time of mastectomy\n* Any patient with a contraindication to immediate breast reconstruction'}, 'identificationModule': {'nctId': 'NCT03064893', 'acronym': 'REaCT-ADM', 'briefTitle': 'The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction', 'orgStudyIdInfo': {'id': 'OTT 16-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dermacell', 'description': 'Device for immediate implant based breast reconstruction', 'interventionNames': ['Device: Dermacell']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alloderm', 'description': 'Device for immediate implant based breast reconstruction', 'interventionNames': ['Device: Alloderm']}], 'interventions': [{'name': 'Alloderm', 'type': 'DEVICE', 'description': 'Reconstruction material', 'armGroupLabels': ['Alloderm']}, {'name': 'Dermacell', 'type': 'DEVICE', 'description': 'Reconstruction material', 'armGroupLabels': ['Dermacell']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Angel Arnaout, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-04-01', 'type': 'RELEASE'}, {'date': '2025-04-17', 'type': 'RESET'}, {'date': '2025-06-23', 'type': 'RELEASE'}, {'date': '2025-07-10', 'type': 'RESET'}, {'date': '2025-11-19', 'type': 'RELEASE'}, {'date': '2025-12-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ottawa Hospital Research Institute'}}}}