Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Part of paid clinical trials in Stanford, California.

Sponsor: Stanford University
Study ID: NCT04534010
Status: Terminated

Conditions

Breast Cancer

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 65 Years
Healthy Volunteers: Accepted

Interventions

NACgraft — DEVICE
Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. A NACgraft is a novel decellularized cadaveric implant derived from human nipples.

Study Details

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.