Nerve Grafting for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Mark Sisco, MD, FACS
Principal Investigator
Endeavor Health
Are You a Good Fit for This Trial?
This trial is for women planning to have both breasts removed with nipple-sparing mastectomy and immediate implant reconstruction. Participants must be eligible for this surgery and willing to have one breast receive a donor nerve graft during the procedure.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic Nerve Grafting
Trial Overview
The study tests if adding a donor nerve graft (Avance Nerve Scaffold) during implant-based breast reconstruction improves sensation in the breast and nipple compared to not using a nerve graft. Each participant receives the graft on only one side, chosen at random.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Endeavor Health
Lead Sponsor
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