Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
Study NCT ID:
NCT00872859
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2009-03-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C440568', 'term': 'Alloderm'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of radiation on acellular dermal matrix', 'timeFrame': 'four years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Cancer of Breast', 'Reconstructive Surgery'], 'conditions': ['Breast Cancer', 'Reconstructive Surgery']}, 'descriptionModule': {'briefSummary': 'Primary Hypothesis:\n\n1\\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction\n\nSecondary hypotheses:\n\n1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.\n2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.\n3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix\n\nSpecific aims:\n\n1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation\n2. Compare the complication rates between the two types of acellular dermal matrix\n3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.\n4. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy\n* Female gender\n* Age between 18 and 80\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Patients not undergoing breast reconstruction following mastectomy\n* Patients undergoing delayed breast reconstruction following mastectomy\n* Patients undergoing immediate definitive breast reconstruction after mastectomy\n* Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction\n* Medical debility precluding surgical treatment\n* Prior breast or chest wall irradiation\n* Pregnant patients\n* Male gender'}, 'identificationModule': {'nctId': 'NCT00872859', 'briefTitle': 'The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial', 'orgStudyIdInfo': {'id': '26658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dermamatrix with radiation', 'interventionNames': ['Procedure: Implantation of Dermal Matrix substitute']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dermamatrix without radiation', 'interventionNames': ['Procedure: Implantation of Dermal Matrix substitute']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Alloderm with radiation', 'interventionNames': ['Procedure: Implantation of Dermal Matrix substitute']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Alloderm without radiation', 'interventionNames': ['Procedure: Implantation of Dermal Matrix substitute']}], 'interventions': [{'name': 'Implantation of Dermal Matrix substitute', 'type': 'PROCEDURE', 'otherNames': ['Dermamatrix', 'Alloderm', 'Dermal Matrix'], 'description': 'Dermal Matrix implanted in post mastectomy pts at time of mastectomy.', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital/ Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jayant Agarwal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Division of Plastic Surgery, Associate Professor of Surgery', 'investigatorFullName': 'Jay Agarwal', 'investigatorAffiliation': 'University of Utah'}}}}