Comparing Four Acellular Dermal Matrix Products in Two-Stage Breast Reconstruction Surgery for Women Aged 21 to 65

What this Trial Is About

Researchers are evaluating four different acellular dermal matrices ADMs used in breast reconstruction after mastectomy. ADMs help support the recreated breast pocket during two-stage tissue expander breast reconstruction. The study aims to compare the surgical outcomes and complications of AlloDerm, DermACELL, AlloMax, and Flex HD over a two-year follow-up to determine which ADM may lead to fewer post-operative issues such as seromas. Participants will be randomly assigned to receive one of the four ADM products during their breast reconstruction surgery. Each group will use the assigned ADM along with tissue expanders followed by implant exchange. For bilateral reconstruction, the same ADM will be used on both sides. This randomized controlled trial will assess differences in complications like seroma formation and other post-operative care measures, initially recruiting 40 patients as a pilot to establish study feasibility. During the study, participants will be monitored for outcomes including incidence of seromas, drain duration and output, hematoma, infections, implant loss, and aesthetic satisfaction. Follow-up will include evaluations up to two years after the second surgical stage. Researchers will collect data through clinical assessments and patient questionnaires to measure surgical results, safety, and satisfaction over this period.

BREAST ADM Trial for Alloplastic Breast Reconstruction