Nipple Sparing Mastectomy - Cosmetic Outcomes

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Reconstruction; Cosmesis
• Interventions: Procedure: Nipple Sparing Mastectomy

• Registration Number: NCT01002014
• Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Study Timeline

• Study Start: 2009-01-21
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2016-08-24
• Study Completion: 2018-09-20
• Status Verified: 2019-01
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nipple Sparing Mastectomy	Nipple Sparing Mastectomy	Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex.

Primary Outcome Measures

Name	Time	Method
Presence of tumor in nipple areolar complex frozen section	Duration of Study
Presence of tumor in nipple areolar complex permanent histology	Duration of study
Cosmetic Appearance	First Post Operative year
Patient Satisfaction	First Post Operative Year

Secondary Outcome Measures

Name	Time	Method
Complications	First Post Operative year
Local Recurrence	One year

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States