Neurotization for Breast Implant Complications

TC
Overseen ByThomas Calahan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

MC

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

I am having both breasts removed without removing the nipples at one hospital.
I am getting breast reconstruction with an implant.

Exclusion Criteria

I have had breast surgery before, such as reduction, augmentation, or lumpectomy.
Current tobacco or nicotine use
History of allergy, sensitivity, or intolerance to porcine-derived materials
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bilateral implant-based breast reconstruction with neurotization on one breast

Surgery and immediate post-operative period

Follow-up

Participants are monitored for return of nipple sensation and overall breast sensation using SWMT

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Breast Neurotization
Trial Overview The study tests if sensory nerve coaptation (breast neurotization) can restore nipple sensation after breast reconstruction. It's a single-blinded randomized controlled trial where each patient gets the procedure on one breast but not the other to compare results.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Neurotized BreastExperimental Treatment1 Intervention
Group II: Non-Neurotized BreastActive Control1 Intervention

Breast Neurotization is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Breast Neurotization for:
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Approved in European Union as Breast Neurotization for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

In a study of 59 patients undergoing breast reconstruction, those who received abdominal flap neurotization with processed human nerve allograft showed a significantly higher return of protective sensation in the reconstructed breast compared to those who did not receive neurotization.
Specifically, 55% of neurotized breasts regained protective sensation in at least 5 out of 9 tested areas, compared to only 7% in non-neurotized breasts, highlighting the efficacy of this technique in improving sensory outcomes post-reconstruction.
Flap Neurotization in Breast Reconstruction with Nerve Allografts: 1-year Clinical Outcomes.Momeni, A., Meyer, S., Shefren, K., et al.[2022]
Neurotization during autologous breast reconstruction significantly improves the return of sensation, as indicated by lower pressure thresholds in neurotized patients compared to non-neurotized controls, although the difference was marginally significant (p = 0.053).
The review included 11 studies with a total of 474 patients, showing that neurotization is a safe and feasible method to enhance sensory outcomes after breast reconstruction, warranting further research with standardized follow-up to better understand its long-term effects.
Is nerve coaptation associated with improved sensation after microvascular breast reconstruction? A systematic review.Chou, J., Hyland, CJ., Kaufman Goldberg, T., et al.[2023]
Direct neurotization (DN) in a rat model successfully generated a new mechano-nociceptive field after sensory denervation, indicating its potential effectiveness for breast neurotization in implant-based breast reconstruction.
By 12 weeks post-surgery, the area of new sensory innervation was significantly larger in the DN dermal group compared to the original innervated region, suggesting that DN can effectively direct nerve regeneration to desired locations even when distal nerve stumps are not available.
Targeted sensory reinnervation by direct neurotization of skin: An experimental study in rats.Taminato, M., Tomita, K., Yano, K., et al.[2021]

Citations

Innervated breast reconstruction: a narrative review of ...Neurotization at the time of breast reconstruction may lead to improved sensation and patient reported outcomes delineating improved quality of life compared to ...
Breast neurotization along with breast reconstruction after .. ...Conclusion: Breast reconstruction with autologous nerve graft neurotization yields improved sensory outcomes and has a statistically significant ...
Review Neurotization in Innervated Breast ReconstructionThis systematic review aimed to synthesize neurotization techniques and outcomes in breast reconstruction surgery.
Sensory reinnervation after mastectomy with implant-based ...The focus of this article is to describe the current state of sensory preservation and reinnervation for mastectomy with implant-based reconstruction.
Nipple Areolar Complex (NAC) Neurotization After ...The authors report reduced NAC sensation in 2 breasts (9%) and reported improvement in one breast (4%). All patients reported intact sensation ...
Breast neurotization along with breast reconstruction after ...Neurotization significantly improves sensory outcomes post-breast reconstruction. Patients with neurotized breasts report better psychosocial ...
The current landscape of sensory neurotization in implant ...Transected or injured nerves during the neurotization process may lead to further diminished sensation or chronic neuropathic pain. To date, there has not been ...
Sensory Outcomes after Neurotization in Nipple-sparing...Performing neurotization during nipple-sparing mastectomy and implant breast reconstruction improves postmastectomy breast and nipple–areolar complex sensation.
Breast neurotization along with breast reconstruction after .. ...Conclusion: Breast reconstruction with autologous nerve graft neurotization yields improved sensory outcomes and has a statistically significant positive impact ...
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