NCT01002014

Nipple Sparing Mastectomy - Cosmetic Outcomes

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Breast Cancer
• Breast Reconstruction
• Cosmesis

Interventions

Type	Name	Description
PROCEDURE	Nipple Sparing Mastectomy	Skin sparing mastectomy with preservation of the nipple areolar complex

Timeline

• Start date: 2009-01-21
• Primary completion: 2016-08-24
• Completion: 2018-09-20
• First posted: 2009-10-27
• Last updated: 2022-04-21

Locations

1 site across 1 country: United States