Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Stanford University

Status

Terminated

Conditions

Breast Cancer

Treatments

Device: NACgraft

Study type

Interventional

Funder types

Other

Identifiers

NCT04534010

IRB-55153

BRS0117 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.