Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft

Study Overview
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Brief Summary
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To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)

Detailed Description
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Primary Objective • To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC). Secondary Objectives To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC. To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC. Exploratory Objectives To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures. To evaluate nipple sensitivity.

Official Title
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Open Label Case Reports Investigating Wound Healing, Aesthetic Outcomes, and Patient Satisfaction Following Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)

Conditions
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Post-Mastectomy Breast Deformity (Disorder)

Intervention / Treatment
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* Procedure: Regenerative post mastectomy surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Criteria: Females age >18 and <65 years old. Women of childbearing potential must agree to use an acceptable method of contraception for one month prior to DCLNAC implantation, and until the graft is 100% healed. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. Nonchildbearing potential for women is defined as postmenopausal (last natural menses greater than 12 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 12 months, a serum FSH value confirming post-menopausal status can be employed. Patient agrees to sleep on back until study tissue products are healed Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until study tissue products are healed Patient agrees to not undergo NAC tattooing until completing study Patient can understand and willing to sign informed consent Patient desires bilateral nipple reconstruction with DCLNAC Subjects must be capable of providing written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA), if applicable] Specific Criteria Group A: Patient had a bilateral mastectomy with no radiation therapy Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study Group B: Patient had a unilateral mastectomy with no radiation therapy Patient has undergone a unilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study Group C: Patient had a bilateral mastectomy and received radiation unilaterally Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study Group D: - Patient had unilateral or bilateral mastopexy (with or without augmentation) or reduction mammaplasty and suffered nipple complications (i.e., necrosis, projection loss) Group E: Patient had unilateral or bilateral mastectomy Patient had unilateral or bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study Patient did not receive radiation to the autologously reconstructed breast Patient had unilateral or bilateral nipple reconstruction that failed (i.e., necrosis, projection loss) Group F: - Implant based reconstruction Exclusion Criteria: Patient has a history of delayed wound healing Patient has a history of Vitamin C deficiency BMI<18.5 or >40 kg/m2 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, vaping or nasal spray) or has used such products in the past 6 months Patient is currently receiving bilateral breast radiation or completed less than 3 months prior to screening Patient has any systemic disease that would impede wound healing, such as diabetes or connective tissue disorders Patient is pregnant, breastfeeding or planning to become pregnant during the study period Patient has any type of disease or disorder that in the investigator's opinion would make the patient unfit for the study, including active infection anywhere in the body. Acute mastitis in either breast History of an autoimmune disorder Use of any medications currently or in the past 3 months that would impair wound healing, such as long-term use of systemic steroids (inhaled, limited topical, short-term oral use and intra-articular steroids are acceptable)

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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No

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: Implant of acellular NAC graft<br>The implantation of the NAC acellular graft for regenerative nipple areolar complex | Procedure: Regenerative post mastectomy surgery<br>* Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)<br>* Other names: Implantation of the NAC graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete healing (graft >99% re-epithelialized) | To evaluate the time to complete healing following NAC reconstruction with DCLNAC. | 3 months | 
| Healing of the nipple (VAS=Visual Analog Scale) epithelialization | epithelialization (0-100% VAS) | 3 months | 
| Healing of the nipple (VAS=Visual Analog Scale) granulation | granulation (0-100% VAS) | 3 months | 
| Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis | ischemia/necrosis (0-100% VAS) | 3 months | 
| Healing of the nipple (VAS=Visual Analog Scale) dehiscence | dehiscence (0-100% VAS) | 3 months | 
| Healing of the nipple (VAS=Visual Analog Scale) overall healing | overall healing (0-100% VAS) | 3 months | 
| Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection | As above | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple projection | Distance from breast mound to tip in millimeters using depth gauge. | 12 months | 
| Vascularization by presence of bleeding | vascularization by presence of bleeding using a lancet device | 12 months | 
| Evaluate patient satisfaction and well-being preoperatively and serially | Use of a standardized postoperative survey with a LIKERT (numerical) scale up to 12 months following reconstruction. | 12 months |