Breast Cancer Clinical Trial

Nipple Sparing Mastectomy – Cosmetic Outcomes

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.

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Full 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.

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Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

75

Study ID:

NCT01002014

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Levine Cancer Institute
Charlotte North Carolina, 28204, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

75

Study ID:

NCT01002014

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

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