Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Breast Reconstruction, Cosmesis
Both
Breast Cancer, Breast Reconstruction, Cosmesis
Trial Information
Preservation of the Nipple Areolar Complex With Skin Sparing 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cosmetic Appearance
Outcome Time Frame:
First Post Operative year
Safety Issue:
No
Principal Investigator
Richard L White, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Carolinas Healthcare
Authority:
United States: Institutional Review Board
Study ID:
01-09-15B
NCT ID:
NCT01002014
Start Date:
January 2009
Completion Date:
Related Keywords:
- Breast Cancer
- Breast Reconstruction
- Cosmesis
- 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
- Breast Neoplasms
Name | Location |
|---|---|
| Carolinas Medical Center - Blumenthal Cancer Center | Charlotte, North Carolina 28204 |
