Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
Study Details
Study Description
Brief Summary
The primary objective of this study is to histologically evaluate the incorporation of AlloMend® Acellular Dermal Matrix into surrounding native soft tissue. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- ADM incorporation with native tissue [At expander/implant exchange surgery; typically 1-3 months post expander placement]
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.
Secondary Outcome Measures
- Infection rates [Up to 6 months post expander/implant exchange]
Information collected through clinical standard of care
- Seroma rates [Up to 6 months post expander/implant exchange]
Information collected through clinical standard of care
- Hematoma rates [Up to 6 months post expander/implant exchange]
Information collected through clinical standard of care
- Drain outputs and timing of drain removal [Up to 6 months post expander/implant exchange]
Information collected through clinical standard of care
- Revision surgeries [Up to 6 months post expander/implant exchange]
Information collected through clinical standard of care
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years of age;
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AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
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Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
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Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.
Exclusion Criteria:
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Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
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Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Janiga MDs Plastic Surgery and Cosmetic Center | Reno | Nevada | United States | 89521 |
Sponsors and Collaborators
- AlloSource
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADM-002