Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Not Recruiting

Trial ID: NCT04534010

Purpose

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)

Eligibility

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.

Intervention(s):

device: NACgraft

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shannon Meyer
650-724-1953

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