Endeavor Health
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. The main questions it aims to answer are: * Does nerve grafting improve objective breast sensation compared with reconstruction without nerve grafting? * Does nerve grafting improve patient-reported breast sensation? Researchers will compare the breast that receives the nerve graft with the breast that does not receive a nerve graft to determine whether nerve grafting improves sensory recovery. Participants will: * Undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction as planned standard care. * Receive an allogeneic nerve graft (Avance Nerve Scaffold) on one breast, with the side receiving the graft determined randomly. * Have breast sensation measured using a light-touch test before surgery and at approximately 6, 12, and 24 months after surgery. * Complete questionnaires about breast sensation at the same time points.
Inclusion Criteria: * Female subjects greater or equal to 22 years of age. * Subject is considered a candidate for nipple sparing mastectomy by the breast and plastic surgeon * First-time breast reconstruction post-mastectomy for target breasts. * Subject is planning to undergo bilateral nipple-sparing mastectomy with immediate, implant-based, subpectoral or prepectoral breast reconstruction. * Mastectomy performed to address ductal carcinoma-in-situ (DCIS) or for cancer prophylaxis. * An informed consent form is signed by subject * Subject is capable of following protocol procedures and comp…
A processed allogeneic nerve graft (Avance Nerve Scaffold) will be used to reconstruct the sensory nerve pathway during bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The breast receiving the nerve graft will be randomly assigned for each participant. The graft will be connected proximally to an identified intercostal nerve and, when an appropriate distal nerve target is identified, connected to the nerve supplying the nipple-areolar complex. When no distal nerve target is identified, the distal graft will be secured to the dermis beneath the nipple. The contralateral breast will undergo the planned implant-based reconstruction without nerve grafting and will serve as the within-subject control.