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Nipple Sparing Mastectomy - Cosmetic Outcomes

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Richard White, Carolinas Healthcare System Identifier:
First received: October 26, 2009
Last updated: February 6, 2017
Last verified: February 2017
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. These 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.

Condition Intervention
Breast Cancer
Breast Reconstruction
Procedure: Nipple Sparing Mastectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

Resource links provided by NLM:

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Cosmetic Appearance [ Time Frame: First Post Operative year ]
  • Patient Satisfaction [ Time Frame: First Post Operative Year ]
  • Presence of tumor in nipple areolar complex frozen section [ Time Frame: Duration of Study ]
  • Presence of tumor in nipple areolar complex permanent histology [ Time Frame: Duration of study ]

Secondary Outcome Measures:
  • Complications [ Time Frame: First Post Operative year ]
  • Local Recurrence [ Time Frame: One year ]

Enrollment: 75
Study Start Date: January 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nipple Sparing Mastectomy
Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex.
Procedure: Nipple Sparing Mastectomy
Skin sparing mastectomy with preservation of the nipple areolar complex


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01002014

United States, North Carolina
Carolinas Medical Center - Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Principal Investigator: Richard L White, MD Carolinas Healthcare
  More Information


Responsible Party: Richard White, Chief, Division of Surgical Oncology, Carolinas Healthcare System Identifier: NCT01002014     History of Changes
Other Study ID Numbers: 01-09-15B
Study First Received: October 26, 2009
Last Updated: February 6, 2017

Keywords provided by Carolinas Healthcare System:
Breast Cancer
Skin Sparing Mastectomy
Breast Cancer Prophylaxis
Nipple Sparing Mastectomy
Nipple Areolar Complex
Breast Reconstruction
Local recurrence following nipple sparing mastectomy
Cosmetic outcomes following nipple sparing mastectomy
Complications following nipple sparing mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 22, 2017