Nipple Sparing Mastectomy - Cosmetic Outcomes
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Treatments
Details and patient eligibility
About
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.
Full description
The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients requiring mastectomy for cancer and/or prophylaxis
- Age greater than or equal to 18 at time of surgery
- BMI less than or equal to 35
- If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2
Exclusion criteria
- Currently smoking
- Prior radiation to the affected breast
- Systemic lupus erythematosus
- Central tumor location and/or tumor within 2 cm of NAC
- Paget's disease of the nipple
- Clinical evidence of tumor involvement in the nipple
- Clinical evidence of axillary nodal tumor involvement
- Lymphovascular invasion of the tumor on core biopsy
Trial design
Primary purpose
Allocation
Interventional model
Masking
75 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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