Research Purpose:
After being diagnosed with breast cancer, breast reconstruction is usually done by forming new breasts using your own skin and a balloon like device called a tissue expander. To help the tissue expander make a pocket for the final breast implant, an acellular dermal matrix is placed under the skin to support the expander. This way, the tissue does not move out of place. Acellular Dermal Matrices (ADMs) are material made from treated human skin to avoid patient reactions. ADMs where first used in breast surgery in 2001 and have been allowed in Canada since 2009. AlloDerm was one of the first ADMs to be developed followed by other brands such as DermACELL, Flex HD, and AlloMax. Each have been shown to be safe for use in breast reconstruction, but these four products have not been compared to each other. The goal of this study is to compare four different acellular dermal matrices used in breast reconstruction to see if they have the same results
What is involved:
Before your surgery, you’ll need to sign a consent form for study participation. If you are eligible and agree to participate, your surgeon will record your medical history. You’ll also fill out the pre-operative BREAST-Q questionnaire and you will be randomly assigned an ADM. Standard procedures will be followed, and a biopsy of your ADM will be taken to assess its healing. Dressing will stay on for at least 48 hours. After surgery, standard post-surgical follow-up appointments are mandatory, scheduled at 1-2 weeks, 4 weeks, 6-8 weeks, 3, 6, 12, and 24 months. Each visit typically lasts around 45 minutes. Additional visits beyond these are not obligatory unless requested by you. At the 1-year mark, before and after your surgery, you’ll complete a brief questionnaire called the BREAST-Q, taking about 10-15 minutes. It evaluates your satisfaction and experiences with breast reconstruction, including factors like bra fit and abdomen appearance. During follow-up visits, your surgeon will conduct a routine physical examination, and standardized photographs of your breasts (excluding your face) will be taken at each visit for documentation.
Who can participate:
All woman aged 21 years or older but less than 65 undergoing mastectomy and breast reconstruction with a tissue expander and ADM will be invited to participate.