Trial Search Results
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
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.
Stanford is currently accepting patients for this trial.
- Device: NACgraft
- 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.
- 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
- 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
- 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
Ages Eligible for Study
18 Years - 65 Years
Genders Eligible for Study