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To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
Full description
Primary Objective
• To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC).
Secondary Objectives
Exploratory Objectives
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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]
Group A:
Group B:
Group C:
Group D:
Group E:
Group F:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
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Central trial contact
Susan Van Vactor; Gerald L. Klein, MD
Data sourced from clinicaltrials.gov
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