Study of Acellular Dermal Matrix in Two-Stage Pre-Pectoral Breast Reconstruction in Adult Women

What this Trial Is About

Researchers are evaluating breast reconstruction techniques in females undergoing a two-stage procedure using a pre-pectoral method. This study compares breast reconstruction using an Acellular Dermal Matrix device called Cortiva Tissue Matrix with reconstruction performed without this matrix. The trial is non-randomized and aims to assess outcomes in women 22 years or older undergoing immediate breast reconstruction after mastectomy. Participants will be assigned to one of two groups breast reconstruction with the Cortiva Tissue Matrix device or reconstruction without the Acellular Dermal Matrix. Both groups will undergo a two-stage breast reconstruction using the pre-pectoral technique following nipple or skin-sparing mastectomy. The study is conducted across multiple centers and does not involve masking or blinding. During the study, participants will be monitored for major adverse events and health-related quality of life over 12 months. Additional assessments include changes in quality of life at one and two years, procedure-related and device-related adverse events at three months, one year, and two years, and histopathology evaluation during the second stage of the procedure. The trial lasts for up to two years, with ongoing safety and quality of life follow-ups.

Acellular Dermal Matrix Investigation in Breast Reconstruction