An interventional study of Nipple Sparing Mastectomy in Breast Cancer, Breast Reconstruction and Cosmesis, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Complications
Time frame: First Post Operative year
Local Recurrence
Time frame: One year
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences