Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
223 participants
OBSERVATIONAL
2019-11-20
2022-06-01
Brief Summary
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Detailed Description
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A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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SimpliDerm HADM
Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.
SimpliDerm HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloDerm HADM
Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.
AlloDerm HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloMax HADM
Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.
AlloMax HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
FlexHD HADM
Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure.
FlexHD HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
DermACELL HADM
Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure.
DermACELL HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Interventions
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SimpliDerm HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloDerm HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloMax HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
FlexHD HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
DermACELL HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Eligibility Criteria
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Inclusion Criteria
* HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Exclusion Criteria
* Female patient who underwent delayed breast reconstruction procedure.
* Female patient who underwent revision of previous breast reconstruction procedure.
FEMALE
No
Sponsors
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Elutia Inc.
INDUSTRY
Responsible Party
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Locations
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Baptist Medical Center South
Montgomery, Alabama, United States
Shoals Plastic Surgery
Muscle Shoals, Alabama, United States
Tierney Plastic Surgery
Nashville, Tennessee, United States
Ascension/Seton Institute of Reconstructive Plastic Surgery
Austin, Texas, United States
DHR Health
McAllen, Texas, United States
Countries
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Related Links
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Aziyo Biologics, Inc.
Other Identifiers
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CLP-0004
Identifier Type: -
Identifier Source: org_study_id
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