Breast Implant; Complications, Infection or Inflammation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
AlloSource
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application | At expander/implant exchange surgery; typically 1-3 months post expander placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed