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Split Chest Breast Neurotization

NCT05757778 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Breast Implant; Complications

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.

Sponsors & Collaborators

Principal Investigators

  • Mihye Choi · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2027-04-07
Completion
2027-04-07

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757778 on ClinicalTrials.gov