Neurotization for Breast Implant Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new technique called breast neurotization (also known as nerve grafting or nerve allograft reconstruction) to determine if it can help women regain nipple sensation after implant-based breast reconstruction. Researchers test this by performing the technique on one breast while leaving the other untouched to compare the results. It suits women undergoing bilateral nipple-sparing mastectomy (removal of breast tissue) who are receiving implants. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve post-surgical outcomes for future patients.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a history of diabetes with a high HgbA1c, auto-immune disease, or allergies to certain materials, you may not be eligible to participate.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that breast neurotization is safe for restoring nipple sensation?
Research shows that breast neurotization can help restore feeling after breast reconstruction. Studies indicate that patients who undergo this procedure often report improved sensation in their breasts, leading to greater comfort and a better quality of life.
However, some concerns exist. The procedure carries a risk of nerve damage, which might result in reduced feeling or ongoing nerve pain. Reports of these negative effects remain limited.
Overall, breast neurotization appears well-received by patients and has shown promising results in helping people regain feeling in their breast area. It is important to discuss potential risks and benefits with a doctor before deciding on any treatment.12345Why are researchers excited about this trial?
Unlike standard breast implant procedures that often leave the reconstructed breast without sensation, breast neurotization aims to restore feeling by connecting nerves to the nipple using nerve grafting techniques. This approach is unique because it targets nerve reconnection, potentially improving sensation and quality of life for patients after mastectomy. Researchers are excited about this technique because it offers hope for a more natural post-surgery experience, addressing a significant gap in current breast reconstruction methods.
What evidence suggests that breast neurotization is effective for restoring nipple sensation in implant-based breast reconstruction?
Research has shown that breast neurotization, a procedure connecting nerves to restore sensation, may improve feeling for patients undergoing breast reconstruction. In this trial, one breast will be neurotized using nerve grafts, while the other will not undergo neurotization, serving as a control. Studies have found that nerve grafts during surgery lead to better sensation in the breast. For example, one study found that patients experienced noticeable improvements in sensation. Another review highlighted that these techniques can make the breast feel more natural after surgery, enhancing quality of life. While more research is needed, early findings suggest that breast neurotization might help restore nipple sensation.26789
Who Is on the Research Team?
Mihye Choi, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for women over 18 who are having a bilateral nipple-sparing mastectomy and implant-based breast reconstruction. It's not for those with BMI >30, large breasts needing big implants, severe nerve damage during surgery, diabetes with poor control (HgbA1c >7%), pregnancy, tobacco use, auto-immune diseases, allergy to pig products or prior breast surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo bilateral implant-based breast reconstruction with neurotization on one breast
Follow-up
Participants are monitored for return of nipple sensation and overall breast sensation using SWMT
What Are the Treatments Tested in This Trial?
Interventions
- Breast Neurotization
Breast Neurotization is already approved in United States, European Union for the following indications:
- Restoration of nipple sensation in patients undergoing implant-based breast reconstruction
- Restoration of nipple sensation in patients undergoing implant-based breast reconstruction
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor