Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
Study Details
Study Description
Brief Summary
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Objective
• To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC).
Secondary Objectives
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To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC.
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To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC.
Exploratory Objectives
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To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures.
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To evaluate nipple sensitivity.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Implant of acellular NAC graft The implantation of the NAC acellular graft for regenerative nipple areolar complex |
Procedure: Regenerative post mastectomy surgery
Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time to complete healing (graft >99% re-epithelialized) [3 months]
To evaluate the time to complete healing following NAC reconstruction with DCLNAC.
- Healing of the nipple (VAS=Visual Analog Scale) epithelialization [3 months]
epithelialization (0-100% VAS)
- Healing of the nipple (VAS=Visual Analog Scale) granulation [3 months]
granulation (0-100% VAS)
- Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis [3 months]
ischemia/necrosis (0-100% VAS)
- Healing of the nipple (VAS=Visual Analog Scale) dehiscence [3 months]
dehiscence (0-100% VAS)
- Healing of the nipple (VAS=Visual Analog Scale) overall healing [3 months]
overall healing (0-100% VAS)
- Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection [3 months]
As above
Secondary Outcome Measures
- Nipple projection [12 months]
Distance from breast mound to tip in millimeters using depth gauge.
- Vascularization by presence of bleeding [12 months]
vascularization by presence of bleeding using a lancet device
- Evaluate patient satisfaction and well-being preoperatively and serially [12 months]
Use of a standardized postoperative survey with a LIKERT (numerical) scale up to 12 months following reconstruction.
Other Outcome Measures
- Operative time in minutes [12 months]
One hour
- Physician Preference and Impressions [12 months]
Using a standardized survey (0-10 VAS Scale)
- Nipple sensitivity up to 12 months [12 months]
Using Semmes Weinstein Monofilament
Eligibility Criteria
Criteria
Inclusion Criteria:
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General Criteria:
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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.
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Patient agrees to sleep on back until study tissue products are healed
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Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until study tissue products are healed
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Patient agrees to not undergo NAC tattooing until completing study
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Patient can understand and willing to sign informed consent
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Patient desires bilateral nipple reconstruction with DCLNAC
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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]
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Specific Criteria
Group A:
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Patient had a bilateral mastectomy with no radiation therapy
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Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group B:
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Patient had a unilateral mastectomy with no radiation therapy
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Patient has undergone a unilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group C:
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Patient had a bilateral mastectomy and received radiation unilaterally
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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:
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Patient had unilateral or bilateral mastectomy
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Patient had unilateral or bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
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Patient did not receive radiation to the autologously reconstructed breast
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Patient had unilateral or bilateral nipple reconstruction that failed (i.e., necrosis, projection loss)
Group F:
- Implant based reconstruction
Exclusion Criteria:
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Patient has a history of delayed wound healing
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Patient has a history of Vitamin C deficiency
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BMI<18.5 or >40 kg/m2
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Patient has a history of allergic reaction to any decellularized biologic matrix product
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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
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Patient is currently receiving bilateral breast radiation or completed less than 3 months prior to screening
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Patient has any systemic disease that would impede wound healing, such as diabetes or connective tissue disorders
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Patient is pregnant, breastfeeding or planning to become pregnant during the study period
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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.
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Acute mastitis in either breast
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History of an autoimmune disorder
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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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- BioAesthetics
Investigators
- Study Chair: Roger Morgan, MD, MedSurgPI, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA002