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Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Breast Reconstruction, Cosmesis

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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 CenterCharlotte, North Carolina  28204