Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Not Applicable

Active, not recruiting

Brief Summary: 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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
NACgraft patients	NACgraft	uni- or bilateral engraftment surgery will be performed

Primary Outcome Measures

Name	Time	Method
Time to healing of implanted NACgraft	14 months	Time to healing for each NACgraft will be as the first weekly visit at which the surgeon and central reviewer deem the graft \>99% epithelialized. This measurement will be reported as the number of weeks to healing. Degree of healing will be based on visual assessment by the surgeon and central reviewer with the following metrics on a visual analog scale (VAS): epithelialization (0-100%); granulation (0-100%); overall healing (0-100%). Photographs will be taken using a standardized 3d imaging device, stored and transmitted securely to a central reviewer for independent review. Time to complete healing will be defined as the first visit at which the surgeon and independent reviewer determine that there is \>99% epithelialization of the graft.

Secondary Outcome Measures

Name	Time	Method

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