Evaluation of SurgiMend® vs. Strattice™ in Direct-to-Implant Breast Reconstruction

This study focuses on women who choose to undergo a risk-reducing mastectomy, a procedure to remove breast tissue to lower the risk of breast cancer. This is often chosen by women with a high genetic risk or those diagnosed with multifocal DCIS. The study aims to improve the immediate breast reconstruction process that follows the mastectomy. Currently, acellular dermal matrixes (ADMs) are used to support the skin and implant during reconstruction. The study aims to find the best ADM for this purpose, to minimize complications and improve patient satisfaction. Two types of ADMs, SurgiMend® and Strattice™, will be evaluated. The study's hypothesis is that both provide equal results in terms of complication rates, patient feedback, and aesthetic appearance. Patients participating in the study will be randomly assigned to receive either SurgiMend® or Strattice™ ADM. The surgical procedure remains the same regardless of the ADM used. Patients will be asked to complete a questionnaire before and 4 and 12 months after their breast reconstruction. This questionnaire, known as BREAST-Q, assesses body image, satisfaction with breasts, and satisfaction with care. Additionally, the aesthetic result of the reconstruction will be evaluated by an investigator at 4 and 12 months. Participants may experience risks associated with the mastectomy and reconstruction, such as wound infection, blood clots, and altered sensation. However, these risks are not related to participation in the study. Participants will need to spend extra time completing questionnaires and attending additional clinical examinations.