Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

Study Overview
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Brief Summary
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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.

Official Title
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Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation

Conditions
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Breast Implant; Complications, Infection or Inflammation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age; AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction; Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant; Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol. Exclusion Criteria: 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; Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADM incorporation with native tissue | 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. | At expander/implant exchange surgery; typically 1-3 months post expander placement | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |