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Study Evaluating Safety and Effectiveness of AlloMend Acellular Dermal Matrix in Pre-Pectoral Breast Reconstruction After Mastectomy
Led by AlloSource · Updated on 2025-11-21
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of AlloMend Acellular Dermal Matrix allograft in women who have undergone pre-pectoral breast reconstruction surgery after a single or double mastectomy. This retrospective study aims to describe and assess the effectiveness and safety of AlloMend in this surgical context, focusing on its use in stabilizing breast implants and minimizing implant loss during reconstruction. AlloMend is a sterile, human-derived acellular dermal matrix made from donated full-thickness skin that has been processed to remove cellular layers. It is used alongside breast implants or tissue expanders in either one-stage direct-to-implant or two-stage expander-to-implant breast reconstruction procedures. The allograft supports the implant position and is designed to integrate into the surgical site, promoting blood vessel growth and reducing inflammation or rejection. Participants in this study have completed or will complete follow-up evaluations at 2 weeks, 6 weeks, 3 months, and 6 months after surgery. Researchers collect descriptive data and assess physical function and quality of life up to six months post-operation. The study involves reviewing medical records retrospectively to evaluate outcomes and monitor safety over this period.
CONDITIONS
Brief Title
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
Research Team
E
Elizabeth Esterl, DNP, MS, RN
P
Paige McHenry, MS, ATC, CCRA
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