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Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Sponsor: Gangnam Severance Hospital
Summary
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction. Breast sensation, including sensation of the nipple-areolar complex, may be diminished or lost following mastectomy because of injury to the sensory nerves supplying the breast skin and nipple-areolar complex. Sensory nerve coaptation may improve sensory recovery after surgery. This study will compare sensory recovery between patients who undergo sensory nerve coaptation and those who do not, with the aim of evaluating whether sensory nerve coaptation improves postoperative breast sensation.
Key Details
Gender
FEMALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-10-27
Completion Date
2033-02-01
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Nerve anastomosis
For the Control Group (Cohort 1): Patients will undergo a nipple-sparing mastectomy and immediate implant-based breast reconstruction using the same ADM-wrapped silicone implant technique without nerve anastomosis. For the Nerve Anastomosis Group (Cohort 2): Patients will undergo a nipple-sparing mastectomy followed by immediate implant-based breast reconstruction. A breast pocket is created beneath the mastectomy flap, and the silicone implant is completely wrapped in an Acellular Dermal Matrix (ADM) to prevent capsular contracture before insertion into the pocket. During the mastectomy, the 3rd to 5th intercostal nerves located on the lateral side of the thoracic cage and the subareolar nerves are meticulously preserved to secure adequate length. Direct end-to-end nerve anastomosis is performed when possible. In cases where a nerve gap prevents direct tension-free closure, an acellular allograft nerve (MegaNerve prime®) is used to bridge the gap via end-to-end anastomosis.