This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
AlloMend® Acellular Dermal Matrix AlloMend® 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. This retrospective study will be performed at one center in the United States. Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.
Study Type
OBSERVATIONAL
Enrollment
100
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.
Janiga MDs Plastic Surgery and Cosmetic Center
Reno, Nevada, United States
Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®
This primary outcome measure will retrospectively collect descriptive data on patients who have undergone single or double mastectomy followed by pre-pectoral breast reconstruction using AlloMend® Acellular Dermal Matrix allograft. Data will be extracted from medical records and will include patient demographics, medical history, surgical techniques, intraoperative and postoperative complications, prescribed medications, and adjuvant treatments such as chemotherapy and radiation. The objective is to characterize patient profiles, surgical outcomes, and potential complications associated with this reconstructive approach.
Time frame: Up to 12-month post-operatively
Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes
This outcome measure will retrospectively assess post-treatment follow-up data, including physical examinations, imaging findings, physical therapy progress, and the incidence of revision surgery. Data will be extracted from patient records to evaluate recovery progress, functional improvements, and any complications or need for additional interventions.
Time frame: Up to 12-month post-operatively
Retrospective Assessment of Patient-Reported Health Status and Quality of Life
This outcome measure will retrospectively evaluate patients' self-reported overall health status and quality of life following surgical intervention. Data will be collected from existing medical records, including patient-reported responses and clinical interviews, to assess perceived well-being, functional limitations, pain levels, and overall satisfaction with treatment outcomes. No specific tool was used to gather their responses.
Time frame: Up to 12 months
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