Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
Conditions
Brief summary
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
Detailed description
AlloMend® Acellular Dermal Matrix is a sterile, ready to use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process. AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.
Interventions
AlloSource, a non-profit supplier of allografts and one of the nation's leading tissue banks, introduced AlloMend® Acellular Dermal Matrix allograft to bring the benefits of regenerative medicine to more patients. cellular allograft matrices, unlike synthetic materials or xenografts, are recognized as human tissue by the body for graft incorporation by the recipient, minimizing the risk of inflammation or rejection. AlloMend® Acellular Dermal Matrix allograft has been shown to incorporate into the surgical site and demonstrates blood vessel infiltration.
Sponsors
AlloSource
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet the following inclusion criteria to participate in this study: * Diagnosed by a physician and required a single or double mastectomy followed by Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft; * Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used; * Has completed or will complete the anticipated clinically indicated follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.
Exclusion criteria
Patients must not meet any of the following criteria to be considered for this clinical trial: * Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction * Did not have post-operative evaluations at the clinical site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Data Collection | Up to 6- months post-operatively | The primary objective is to obtain descriptive data and surgical intervention and post operative surgical outcome data on AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function and Quality of Life | Up to 6- months post-operatively | Secondary Objectives will identify changes in physical function and quality of life as assessed for a period of 6-months post-operatively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Data | Up to 6- months post-operatively | Qualitative data such as return to wound healing, pain, discomfort, physicial deformity, and revision surgeries will also be collected. |
Countries
United States
Contacts
Primary ContactElizabeth Esterl, DNP, MS, RN
Backup ContactPaige McHenry, MS, ATC, CCRA
Outcome results
None listed