Sensory Restoration Surgery for Breast Reconstruction

Overseen By Gedge D Rosson, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Diabetic neuropathy, Thyroid disorders, Alcoholism, 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: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve sensation in reconstructed breasts by using a special nerve graft during surgery. It focuses on women undergoing breast reconstruction with tissue from their abdomen after a mastectomy. Participants will be divided into two groups: one will receive the nerve graft technique, known as DIEP Flap Neurotization, to potentially restore feeling, while the other will not. Women planning to have a single breast reconstructed with their own tissue might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-mastectomy breast reconstruction outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have conditions like diabetic neuropathy or are taking medications that cause neuropathy, you may not be eligible to participate.

What prior data suggests that this surgical technique is safe for breast reconstruction?

Research has shown that DIEP flap neurotization, a technique used in breast reconstruction, is generally well-tolerated. This procedure involves transferring tissue from the abdomen to the chest to help restore breast sensation. Studies have found that the Avance® Nerve Graft reduces the need to harvest additional nerves from other body parts, thereby avoiding complications like infection or loss of sensation at the donor site.

Safety reports from past surgeries using the DIEP flap method are encouraging. Patients have not experienced major issues directly related to the nerve graft, making the procedure safer than traditional methods that require extra nerve material from the patient's body. Overall, using the Avance® Nerve Graft in breast reconstruction appears to be a safe option, with the added benefit of potentially restoring sensation more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional breast reconstruction techniques, which often focus solely on aesthetic outcomes, DIEP Flap Neurotization aims to restore sensation by reconnecting nerves during reconstruction. Most current options, like the standard DIEP flap procedure, do not include this nerve reconnection, leaving many patients with reduced or no sensation in the reconstructed breast. Researchers are excited about DIEP Flap Neurotization because it has the potential to significantly improve quality of life by restoring feeling, which could enhance emotional and physical recovery after surgery. This innovative approach represents a step forward in making breast reconstruction not just about appearance, but also about regaining a sense of normalcy.

What evidence suggests that DIEP Flap Neurotization is effective for breast sensory restoration?

Research has shown that a technique called DIEP flap neurotization, which participants in this trial may receive, can restore sensation in the breast after reconstruction surgery. Studies have found that connecting tissue from the abdomen to nerves in the chest allows patients to regain some feeling. This method uses the Avance® Nerve Graft, which links nerves without requiring additional nerve material from another part of the body, thereby reducing risks like numbness and infection. Although more research is needed, early results suggest this technique might restore sensation more effectively than methods that do not connect nerves, such as the approach used for non-neurotized patients in this trial. Overall, the aim is to help the reconstructed breast feel more natural. ^{1 2 3 6 7}

Who Is on the Research Team?

Gedge D Rosson, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for women over 18 who are undergoing unilateral mastectomy and breast reconstruction using their own abdominal tissue (DIEP flap). They must understand the study and consent to participate. Excluded are pregnant or lactating women, those with previous reconstructions or lumpectomy with radiation, recurrent breast cancer, and conditions like diabetic neuropathy or severe peripheral neuropathy.

Inclusion Criteria

The patient is aware of the nature of her malignancy if a malignancy has been diagnosed; understands the study purpose, requirements, and risks; and is able and willing to sign an informed consent.

I am planning to have a mastectomy and DIEP flap reconstruction at Johns Hopkins.

I will be assigned to one of two breast reconstruction methods, with or without nerve connection.

Exclusion Criteria

I do not have conditions like diabetic neuropathy, thyroid disorders, or severe nerve damage from other causes.

Pregnant or lactating women will be excluded from this study.

I have not had breast reconstruction or lumpectomy with radiation before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Breast reconstruction using DIEP flap neurotization with or without Avance® Nerve Graft

Immediate (surgery duration)

1 visit (in-person for surgery)

Follow-up

Participants are monitored for breast sensation and quality of life improvements

24 months

Regular follow-up visits at 6, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• DIEP Flap Neurotization

Trial Overview The trial tests sensory restoration in reconstructed breasts. Participants will be randomly assigned to receive DIEP flap reconstruction with neurotization using Avance® Nerve Graft (to connect nerves from abdomen to chest) or without neurotization. The goal is to see if sensation can be restored more effectively with the nerve graft.

How Is the Trial Designed?

Group I: Neurotized Patients Experimental Treatment 1 Intervention

Neurotization will be performed at the time of reconstruction.

Group II: Non-Neurotized Patients Active Control 1 Intervention

No Neurotization will be performed at the time of reconstruction.

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

Approved in United States as DIEP Flap Neurotization for:

• Breast reconstruction after mastectomy
• Restoration of breast sensation

Approved in European Union as DIEP Flap Neurotization for:

• Breast reconstruction after mastectomy
• Restoration of breast sensation

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Axogen Corporation

Industry Sponsor

Trials

11

Recruited

5,600+

Published Research Related to This Trial

In a study of 67 patients undergoing DIEP flap breast reconstruction, those who received innervated flaps showed significantly better sensory recovery in the reconstructed breast compared to those with noninnervated flaps, indicating the effectiveness of nerve coaptation.

The sensory recovery at the donor site was not negatively affected by the nerve coaptation, suggesting that this technique can enhance breast sensation without compromising the donor area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction. Beugels, J., Bijkerk, E., Lataster, A., et al.[2021]

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]

In a study of 30 breast cancer patients undergoing DIEP flap reconstruction, significant sensory recovery was observed at 6 and 12 months post-surgery, indicating that the procedure allows for progressive return of sensation without the need for nerve repair.

The best sensory recovery occurred in the inferior lateral quadrant of the flap, suggesting that while some areas recover better than others, overall, the DIEP flap provides satisfactory sensory outcomes, allowing surgeons to potentially reduce operative time by not focusing on nerve coaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective computerized analyses of sensibility in breast reconstruction with non-reinnervated DIEP flap. Santanelli, F., Longo, B., Angelini, M., et al.[2022]

Patients who underwent skin-sparing mastectomies with nonburied DIEP flap reconstruction experienced significantly better inner breast region sensation at 6 months post-surgery compared to their baseline levels, indicating quicker sensory recovery.

In contrast, those with buried DIEP flaps from nipple-sparing mastectomies showed no significant improvement in sensation at 6 months, with recovery to baseline levels occurring later, around 24 months postoperatively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Comparing Sensation in Buried Versus Nonburied Deep Inferior Epigastric Perforator Flaps. Lu Wang, M., Qin, N., Chadab, TM., et al.[2023]

The study of 29 women who underwent breast reconstruction with DIEAP flaps showed that these flaps can spontaneously reinnervate, providing measurable sensation in 29 out of 30 flaps, despite no direct sensory nerve repair.

Pressure sensitivity was significantly better in the inferomedial part of the flap compared to other areas, suggesting that nerve ingrowth occurs from the sides of the flap, enhancing sensory recovery in specific regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous reinnervation of deep inferior epigastric artery perforator flaps after secondary breast reconstruction. Tindholdt, TT., Tønseth, KA.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04533373

Sensory Restoration After DIEP Flap Neurotization See Delay Results Type in the Results Data Element ... reconstruction with autologous deep inferior epigastric perforator flap (DIEP) will be included.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624000225

The efficacy of sensory nerve coaptation in DIEP flap ... We initiated the first double-blind randomized controlled trial (RCT), comparing sensory recovery of innervated and non-innervated deep inferior epigastric ...

3. abs.amegroups.org abs.amegroups.org/article/view/9407/html

Sensory reinnervation of reconstructed breasts—a narrative ... This review explores the effectiveness of deep inferior epigastric perforator (DIEP) flap neurotization and targeted nipple reinnervation (TNR), and their ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11921263/

Nerve coaptation in deep inferior epigastric perforator ... The deep inferior epigastric perforator (DIEP) flap is the gold standard flap in autologous breast reconstruction (8). Along with the growing ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004315/

Striving for higher levels of evidence in sensory restoration in ... Spontaneous Reinnervation of Deep Inferior Epigastric Perforator Flaps after Delayed Breast Reconstruction. J Reconstr Microsurg 2016;32:169 ...

6. mdpi.com mdpi.com/2077-0383/13/13/3826

Restoring Sensation through Abdominal Flap Neurotization ... Spontaneous Reinnervation of Deep Inferior Epigastric Perforator Flaps after Delayed Breast Reconstruction. J. Reconstr. Microsurg. 2016, 32 ...

7. journals.lww.com journals.lww.com/prsgo/fulltext/2013/11000/breast_reinnervation__diep_neurotization_using_the.1.aspx

Breast Reinnervation: DIEP Neurotization Using the Third... Methods: Fifty-seven deep inferior epigastric perforator (DIEP) flaps were performed on 35 patients. Neurotizations were performed to the third anterior ...