Status:
COMPLETED
Nipple Sparing Mastectomy - Cosmetic Outcomes
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Breast Cancer
Breast Reconstruction
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01002014
Start Date
January 21 2009
End Date
September 20 2018
Last Update
April 21 2022
Active Locations (1)
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1
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204