Split Chest Breast Neurotization

NYU Langone Health

Status: Active, not recruiting

Conditions: Breast Implant; Complications

Treatments: Procedure: Sensory Nerve Coaptation

Study type: Interventional

Funder types: Other

Identifiers

NCT05757778

22-01026

Details and patient eligibility

About

Several members of the scientific community have suggested that breast neurotization can help return nipple sensation to patients undergoing implant-based breast reconstruction. There has been no randomized controlled study assessing the validity of these claims. The goal of this study is to evaluate if performing breast neurotization can help restore or improve return of nipple sensation to patients undergoing implant-based breast reconstruction. This will be a single-blinded, randomized controlled trial where patients undergoing bilateral reconstruction will serve as their own controls by receiving an intervention on one breast but not the other breast.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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/m2 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 HgbA1c > 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, the investigators 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

6 participants in 2 patient groups

Neurotized Breast

Experimental group

Description:

For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will be neurotized by connecting the lateral intercostal nerve to the nipple with interposing standard nerve grafting techniques. The neurotized breast will serve as the "experimental" breast. The other breast will not receive any breast neurotizing procedure.

Treatment:

Procedure: Sensory Nerve Coaptation

Non-Neurotized Breast

No Intervention group

Description:

For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will not receive any breast neurotizing procedure. The non-neurotized breast will serve as the "control" breast.