Neurotization for Breast Implant Complications

Overseen By Thomas Calahan

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Prior breast surgery, Radiation, BMI > 30, Tobacco use, Diabetes, Auto-immune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 safety data exists for breast neurotization treatments?

Breast neurotization is considered a safe procedure with minimal risk for morbidity. Studies have shown successful clinical and patient-reported outcomes, with techniques like nerve grafting and allografting being effective in preserving or improving sensation. In one study, 90% of patients had preserved sensation after nerve grafting, with no reports of dysesthesias or neuromas. Overall, neurotization techniques are associated with improved sensory outcomes and are deemed safe and effective. ^{1 2 3 4 5}

Is breast neurotization safe for humans?

Breast neurotization is considered a safe procedure with minimal risk for complications, and studies have shown it can preserve or improve sensation in reconstructed breasts without causing issues like pain or nerve damage. ^{1 2 3 4 5}

Is Breast Neurotization a promising treatment for breast implant complications?

Yes, Breast Neurotization is a promising treatment. It helps restore sensation in the breast after surgery, which is often lost. Studies show that it can improve sensory outcomes and patient satisfaction, with a high success rate in preserving or improving sensation. It is also considered safe with minimal risks. ^{1 2 5 6 7}

How does the treatment Breast Neurotization differ from other treatments for breast implant complications?

Breast Neurotization is unique because it focuses on restoring sensation by reconnecting nerves during breast reconstruction, which is not typically addressed by other treatments. This approach uses nerve grafts to improve sensory outcomes, offering a novel solution for the common issue of lost sensation after mastectomy and reconstruction. ^{1 2 5 6 7}

What data supports the idea that Neurotization for Breast Implant Complications is an effective treatment?

The available research shows that neurotization for breast implant complications is effective in restoring sensation. In one study, 90% of women who underwent the treatment had preserved sensation in their reconstructed breasts. Additionally, none of the women experienced negative side effects like pain or nerve damage. This suggests that neurotization is a safe and effective way to improve sensation after breast reconstruction. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment for breast neurotization?

Research shows that nerve grafting and preservation during breast reconstruction can effectively restore sensation, with 90% of patients experiencing preserved or improved sensation. This suggests that neurotization techniques can be beneficial in addressing sensory loss after breast implant procedures. ^{1 2 3 6 7}

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

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.

I am scheduled for radiation before or after surgery.

Current tobacco or nicotine use

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?

Group I: Neurotized Breast Experimental Treatment 1 Intervention

For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will be neurotized by connecting the lateral intercostal nerve to the nipple with interposing standard nerve grafting techniques. The neurotized breast will serve as the "experimental" breast. The other breast will not receive any breast neurotizing procedure.

Group II: Non-Neurotized Breast Active Control 1 Intervention

For patients undergoing bilateral implant-based breast reconstruction following nipple-sparing mastectomy, one breast will not receive any breast neurotizing procedure. The non-neurotized breast will serve as the "control" breast.

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

Approved in United States as Breast Neurotization for:

• Restoration of nipple sensation in patients undergoing implant-based breast reconstruction

Approved in European Union as Breast Neurotization for:

• Restoration of nipple sensation in patients undergoing implant-based breast reconstruction

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A novel technique for breast reconstruction after nipple-sparing mastectomy (NSM) was developed, focusing on preserving intercostal nerves and utilizing nerve grafting, which resulted in an impressive 90% rate of preserved sensation in the reconstructed breasts.

Among the 12 women followed for at least 3 months, 87% maintained normal two-point discrimination at the nipple/areolar complex, and all patients reported intact sensation to light touch, indicating that this approach is both safe and effective for improving sensory outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve Preservation and Allografting for Sensory Innervation Following Immediate Implant Breast Reconstruction. Peled, AW., Peled, ZM.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flap Neurotization in Breast Reconstruction with Nerve Allografts: 1-year Clinical Outcomes. Momeni, A., Meyer, S., Shefren, K., et al.[2022]

Breast neurotization can significantly improve sensory outcomes for postmastectomy patients, addressing the common issue of absent or diminished breast sensation.

The procedure is considered safe with minimal risk of complications, making it a promising area for further research in enhancing patient recovery and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern Approaches to Breast Neurotization. O'Neill, RC., Spiegel, AJ.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted sensory reinnervation by direct neurotization of skin: An experimental study in rats. Taminato, M., Tomita, K., Yano, K., et al.[2021]

In a study of 8 children aged 3-7 years with late obstetric brachial plexus lesions, end-to-side neurotization significantly improved motor power and cocontractions in various muscles, particularly in those with Grade 2 strength or higher.

The results showed that nerve augmentation led to better recovery in proximal muscles compared to distal ones, and improvements were noted in shoulder, elbow, and hand function, although the small sample size limits the conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentation of partially regenerated nerves by end-to-side side-to-side grafting neurotization: experience based on eight late obstetric brachial plexus cases. Amr, SM., Moharram, AN., Abdel-Meguid, KM.[2020]

Neurotization techniques used during immediate DIEP flap breast reconstructions significantly improve breast sensation and sensory recovery compared to delayed reconstructions, highlighting their efficacy in enhancing patient outcomes.

The procedure is described as rapid and simple with minimal morbidity, making it a promising option for restoring breast sensation and increasing patient satisfaction after mastectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-mastectomy sensory recovery and restoration. Hamilton, KL., Kania, KE., Spiegel, AJ.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Nerve Preservation and Allografting for Sensory Innervation Following Immediate Implant Breast Reconstruction. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Flap Neurotization in Breast Reconstruction with Nerve Allografts: 1-year Clinical Outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Modern Approaches to Breast Neurotization. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Is nerve coaptation associated with improved sensation after microvascular breast reconstruction? A systematic review. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted sensory reinnervation by direct neurotization of skin: An experimental study in rats. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Augmentation of partially regenerated nerves by end-to-side side-to-side grafting neurotization: experience based on eight late obstetric brachial plexus cases. [2020]

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Post-mastectomy sensory recovery and restoration. [2021]