Post-Mastectomy Breast Deformity (Disorder) Clinical Trial
Official title:
Open Label Case Reports Investigating Wound Healing, Aesthetic Outcomes, and Patient Satisfaction Following Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
Primary Objective • To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC). Secondary Objectives - To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC. - To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC. Exploratory Objectives - To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures. - To evaluate nipple sensitivity. ;