Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?

Conditions

• Breast Reconstruction Following Mastectomy

Eligibility Criteria

Sex

FEMALE

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Nerve Grafting — BIOLOGICAL
  A processed allogeneic nerve graft (Avance Nerve Scaffold) will be used to reconstruct the sensory nerve pathway during bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The breast receiving the nerve graft will be randomly assigned for each participant. The graft will be connected proximally to an identified intercostal nerve and, when an appropriate distal nerve target is identified, connected to the nerve supplying the nipple-areolar complex. When no distal nerve target is identified, the distal graft will be secured to the dermis beneath the nipple. The contralateral breast will undergo the planned implant-based reconstruction without nerve grafting and will serve as the within-subject control.

Study Details

The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. The main questions it aims to answer are: * Does nerve grafting improve objective breast sensation compared with reconstruction without nerve grafting? * Does nerve grafting improve patient-reported breast sensation? Researchers will compare the breast that receives the nerve graft with the breast that does not receive a nerve graft to determine whether nerve grafting improves sensory recovery. Participants will: * Undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction as planned standard care. * Receive an allogeneic nerve graft (Avance Nerve Scaffold) on one breast, with the side receiving the graft determined randomly. * Have breast sensation measured using a light-touch test before surgery and at approximately 6, 12, and 24 months after surgery. * Complete questionnaires about breast sensation at the same time points.

Key Dates

First listed

Sep 14, 2026

Start date

Dec 31, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Allogeneic Nerve Grafting
  Participants will undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The side receiving nerve grafting will be randomly assigned for each participant. The contralateral breast will undergo standard reconstruction without nerve grafting and will serve as the within-subject control. Participants and study personnel performing sensory assessments will be blinded to treatment allocation.
• No Intervention: No Nerve Grafting
  Participants will undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The side receiving nerve grafting will be randomly assigned for each participant. The contralateral breast will undergo standard reconstruction without nerve grafting and will serve as the within-subject control. Participants and study personnel performing sensory assessments will be blinded to treatment allocation.

Primary Outcome Measure

Breast Sensation Measured by Semmes-Weinstein Monofilament Testing [ Time Frame: Baseline, 6 months, 12 months, and 24 months after surgery ]

Central Contacts

• Grace K Jukovich, MPH
  847-570-1184
  [email protected]
• Mark Sisco, MD, FACS
  847-504-2300
  [email protected]

Locations (3)

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