Split Chest Breast Neurotization

Running, not enrolling · Not applicable

Conditions studied: Breast Implant; Complications

In brief

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.

Key facts

Study ID

NCT05757778

Run by

NYU Langone Health

People needed

6

Starts

2023-08-08

Expected to finish

2027-04-07

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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