Nipple Sparing Mastectomy - Cosmetic Outcomes



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:January 21, 2009
End Date:September 20, 2018

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Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

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.

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.

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
We found this trial at
1
site
Charlotte, North Carolina 28211
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mi
from
Charlotte, NC
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