Breast Cancer, Breast Reconstruction, Cosmesis
Conditions
Keywords
Breast Cancer, Skin Sparing Mastectomy, Breast Cancer Prophylaxis, Nipple Sparing Mastectomy, Nipple Areolar Complex, Mastectomy, Breast Reconstruction, Local recurrence following nipple sparing mastectomy, Cosmetic outcomes following nipple sparing mastectomy, Complications following nipple sparing mastectomy
Brief summary
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.
Detailed 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.
Interventions
PROCEDURENipple Sparing Mastectomy
Skin sparing mastectomy with preservation of the nipple areolar complex
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cosmetic Appearance | First Post Operative year |
| Patient Satisfaction | First Post Operative Year |
| Presence of tumor in nipple areolar complex frozen section | Duration of Study |
| Presence of tumor in nipple areolar complex permanent histology | Duration of study |
Secondary
| Measure | Time frame |
|---|---|
| Complications | First Post Operative year |
| Local Recurrence | One year |
Countries
United States
Outcome results
None listed