Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts


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Trial ID: NCT04534010


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.

Official Title

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

Stanford Investigator(s)


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

   - 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


device: NACgraft


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shannon Meyer

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