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This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.
AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.
The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.
This study will be performed at one (1) clinical center in the United States.
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| Measure | Description | Time Frame |
|---|---|---|
| AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application | The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen. | At expander/implant exchange surgery; typically 1-3 months post expander placement |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rates | Information collected through clinical standard of care | Up to 6 months post expander/implant exchange |
| Seroma rates | Information collected through clinical standard of care |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janiga MDs Plastic Surgery and Cosmetic Center | Reno | Nevada | 89521 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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At the time of exchange of tissue expanders to permanent breast implant, tissue specimens of AlloMend® Acellular Dermal Matrix and native tissue will be obtained from eligible and consented patients for histological analysis.
| Up to 6 months post expander/implant exchange |
| Hematoma rates | Information collected through clinical standard of care | Up to 6 months post expander/implant exchange |
| Drain outputs and timing of drain removal | Information collected through clinical standard of care | Up to 6 months post expander/implant exchange |
| Revision surgeries | Information collected through clinical standard of care | Up to 6 months post expander/implant exchange |