Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft

The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.

Inclusion Criteria:

• Patient age 18-65
• Patient desires NAC grafting ≥3 months after autologous breast reconstruction
• Patient agrees to sleep on back until grafts healed (6 weeks)
• Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
• Patient agrees to not undergo NAC tattooing until completing study (12 months)
• Patient is able to understand and willing to sign informed consent.

Exclusion Criteria:

• History of delayed wound healing
• history of Vitamin C deficiency
• history of diabetes (Type I or Type II)
• current BMI<18.5 or >40 kg/m,
• patient has any other uncontrolled comorbidity.
• Patient has a history of allergic reaction to any decellularized biologic matrix product.
• Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
• Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
• Patient has a history of prior NAC reconstruction
• Patient has had NAC tattooing.
• Patient is pregnant, breastfeeding or planning to become pregnant during the study period.