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To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SimpliDerm HADM | Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure. |
| |
| AlloDerm HADM | Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure. |
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| AlloMax HADM | Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure. |
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| FlexHD HADM | Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure. |
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| DermACELL HADM | Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SimpliDerm HADM | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Events | Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process | From date of surgery through study completion, an average of 9 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Integration Assessment | Integration assessment for patients with two-stage reconstruction at time of exchange, if available, via surgeon's operative notes | From date of surgery through study completion, an average of 9 months |
| Drain Removal |
Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center South | Montgomery | Alabama | 36116 | United States | ||
| Shoals Plastic Surgery |
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| Label | URL |
|---|---|
| Aziyo Biologics, Inc. | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| AlloDerm HADM | Other | 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. |
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| AlloMax HADM | Other | 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. |
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| FlexHD HADM | Other | 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. |
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| DermACELL HADM | Other | 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. |
|
Time to drain removal and volume of fluid drained, if available
| From date of surgery through study completion, an average of 9 months |
| Intraoperative fill volume | Intraoperative fill volume | From date of surgery through study completion, an average of 9 months |
| Muscle Shoals |
| Alabama |
| 35661 |
| United States |
| Tierney Plastic Surgery | Nashville | Tennessee | 37203 | United States |
| Ascension/Seton Institute of Reconstructive Plastic Surgery | Austin | Texas | 78731 | United States |
| DHR Health | McAllen | Texas | 78504 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |