Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-28 @ 1:36 PM
Study NCT ID:
NCT02372305
Status:
WITHDRAWN
Last Update Posted:
2018-07-18
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
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': 'C582618', 'term': 'FlexHD'}, {'id': 'C440568', 'term': 'Alloderm'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI is no longer at institution. IRB closed study due to lack of response from PI', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Dehiscence', 'timeFrame': 'One Year', 'description': 'time frame.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Neoplasm']}, 'referencesModule': {'references': [{'pmid': '25289313', 'type': 'BACKGROUND', 'citation': 'Yuen JC, Yue CJ, Erickson SW, Cooper S, Boneti C, Henry-Tillman R, Klimberg S. Comparison between Freeze-dried and Ready-to-use AlloDerm in Alloplastic Breast Reconstruction. Plast Reconstr Surg Glob Open. 2014 Apr 7;2(3):e119. doi: 10.1097/GOX.0000000000000061. eCollection 2014 Mar.'}, {'pmid': '23636114', 'type': 'BACKGROUND', 'citation': 'Liu DZ, Mathes DW, Neligan PC, Said HK, Louie O. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014 May;72(5):503-7. doi: 10.1097/SAP.0b013e318268a87c.'}, {'pmid': '22868313', 'type': 'BACKGROUND', 'citation': 'Brooke S, Mesa J, Uluer M, Michelotti B, Moyer K, Neves RI, Mackay D, Potochny J. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012 Oct;69(4):347-9. doi: 10.1097/SAP.0b013e31824b3d97.'}]}, 'descriptionModule': {'briefSummary': 'FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.', 'detailedDescription': 'FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\<30\n* No Prior Breast Radiation\n* No Prior Breast Reduction\n* No Diabetes Mellitus (IDDM and non-IDDM)\n* Non-smoker or quit \\>6 weeks prior\n* No breast implants or prior breast implants\n* No inflammatory or autoimmune disorders\n* No current anticoagulation therapy\n* No current pregnant\n\nExclusion Criteria:\n\n* BMI \\> 30\n* Prior Breast Radiation\n* Diabetes Mellitus - IDDM and non IDDM\n* Prior Breast Reduction\n* Active Smoker or Recently Quit \\<6 weeks\n* Prior Breast Implants\n* Inflammatory/Autoimmune Condition (ex. Lupus)\n* Current Anticoagulation Therapy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02372305', 'briefTitle': 'Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery', 'orgStudyIdInfo': {'id': '203456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FlexHD', 'description': 'Patients randomly assigned to receive FlexHD for breast reconstruction.', 'interventionNames': ['Biological: FlexHD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alloderm', 'description': 'Patients randomly assigned to receive Alloderm for breast reconstruction.', 'interventionNames': ['Biological: Alloderm']}], 'interventions': [{'name': 'FlexHD', 'type': 'BIOLOGICAL', 'description': 'Patients will be randomized to receive FlexHD.', 'armGroupLabels': ['FlexHD']}, {'name': 'Alloderm', 'type': 'BIOLOGICAL', 'description': 'Patient will be randomized to receive Alloderm.', 'armGroupLabels': ['Alloderm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Pallavi A Kumbla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UAMS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}