Breast Neurotization to Promote the Return of Nipple Sensation in Patients Undergoing Nipple Sparing Mastectomy with Bilateral Implant-Based Breast Reconstruction Surgery

Status: closed to accrual

This clinical trial tests how well breast neurotization works to promote the return of nipple sensation in patients undergoing nipple sparing mastectomy with bilateral implant-based breast reconstruction surgery. Following mastectomy, sensation to the breast and nipple areolar complex can be diminished or eliminated. While sensation may return to varying degrees, often post-mastectomy sensation is diminished from pre-mastectomy levels. Breast neurotization is the surgical procedure of helping restore sensation to the breast following a mastectomy. This procedure involves connecting the native nerves of the chest to the nipple through nerve grafts or nerve connectors in order to help facilitate nerve regrowth and sensation to the breast and nipple areolar complex. Undergoing breast neurotization may result in more nipple sensation in patients undergoing a mastectomy with breast reconstruction surgery.

Inclusion Criteria

Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution
Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size)
Age 18 or older

Exclusion Criteria

Women with history of prior breast surgery given concern for potentially damaged nerves by prior intervention that could impact the procedure and results. Procedures include but are not limited to: prior breast reduction, prior breast augmentation, prior lumpectomy
Pre-operative radiation or anticipated post-operative radiation
Body mass index (BMI) > 30 kg/m^2 or patients with macromastia (larger breasts) as these patients frequently require larger implants that will not accommodate the longest nerve graft available (70 mm)
Current tobacco or nicotine use
History of diabetes mellites with a hemoglobin (Hgb)A1c > 7% due to lower rates of wound healing
History of auto-immune disease
History of allergy, sensitivity, or intolerance to porcine-derived materials
Intraoperatively, patients may have to be excluded if during the mastectomy the lateral nerve targets were severely damaged or removed as part of the mastectomy. While these patients will be excluded from the formal analysis, we will continue to follow them as a subgroup for analysis and comparison
Men as they infrequently receive bilateral mastectomies due to breast cancer. Male breast cancer is < 1% of all breast malignancies
Pregnancy as determined by urine pregnancy test on day of surgery

PRIMARY OBJECTIVE:

I. To assess the effect of breast neurotization following nipple-sparing mastectomy by comparing return of nipple sensation in the neurotized breast versus the untreated breast within the same patient.

SECONDARY OBJECTIVE:

I. To assess patient perception of breast reconstruction and quality of life following breast neurotization while assessing for perceived differences between the neurotized and non-neurotized breast.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo nipple sparing mastectomy with implant-based breast reconstruction on both breasts and undergo breast neurotization on the right breast.

ARM II: Patients undergo nipple sparing mastectomy with implant-based breast reconstruction on both breasts and undergo breast neurotization on the left breast.

Patients undergo Semmes-Weinstein monofilament test (SWMT) throughout the study.

Following completion of study intervention, patients are followed up at 1-2 weeks,1, 3, 6, 12 and 24 months.

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Breast Neurotization to Promote the Return of Nipple Sensation in Patients Undergoing Nipple Sparing Mastectomy with Bilateral Implant-Based Breast Reconstruction Surgery

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