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ACTIVE NOT RECRUITING
NCT05757778
NA

Split Chest Breast Neurotization

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Blind, Split-Chest, Single-Center Study of the Effects of Breast Neurotization in Implant Based Breast Reconstruction

Key Details

Gender

FEMALE

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2023-08-08

Completion Date

2027-04-07

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

PROCEDURE

Sensory Nerve Coaptation

Nerve reconstruction will employ an off-the-shelf nerve graft coapted to the donor anterior intercostal nerve branch laterally and medially at the underside of the nipple. The anterior intercostal nerve branch and nerve graft coaptation will be performed in a standard fashion with a 1 mm gap between the ends of the graft and the donor nerve. Medially, the nerve graft will be inset into the underside of the preserved nipple-areola complex using 8-0 or 9-0 epineural stitches from the nerve allograft. All nerve coaptations will be performed under loupe magnification as is standardly performed.

Locations (1)

NYU Langone Health

New York, New York, United States