Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: NACgraft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NACgraft patients<br>uni- or bilateral engraftment surgery will be performed | Device: NACgraft<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing of implanted NACgraft | 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. | 14 months |