Post-Mastectomy Breast Deformity (Disorder)
Conditions
Brief summary
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
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 * 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.
Interventions
PROCEDURERegenerative post mastectomy surgery
Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)
Sponsors
BioAesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactSusan Van Vactor
Backup ContactGerald L. Klein, MD
Outcome results
None listed