Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nipple Sparing Mastectomy - Cosmetic Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01002014
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Richard White, Atrium Health

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Reconstruction Cosmesis Procedure: Nipple Sparing Mastectomy Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy
Actual Study Start Date : January 21, 2009
Actual Primary Completion Date : August 24, 2016
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Mastectomy

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002014


Locations
Layout table for location information
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
Investigators
Layout table for investigator information
Principal Investigator: Richard L White, MD Carolinas Healthcare
Publications:

Layout table for additonal information
Responsible Party: Richard White, Chief, Division of Surgical Oncology, Atrium Health
ClinicalTrials.gov Identifier: NCT01002014    
Other Study ID Numbers: LCI NAC-SSM
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Richard White, Atrium Health:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases