Neodyne Device for Scar Improvement in Breast Reconstruction

Overseen by Arash Momeni, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Must not be taking: Steroids

Disqualifiers: Collagen vascular disease, Scleroderma, Smoking, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a special device called the Neodyne embrace to see if it can make scars look better after breast reconstruction surgery. It focuses on women who have had this surgery using tissue from their abdomen. The device works by reducing skin tension around the scar, which helps it heal more nicely.

Will I have to stop taking my current medications?

If you are taking steroid therapy (either systemic or inhaled), you will need to stop at least 2 months before joining the study. For other medications, the protocol does not specify any requirements.

What data supports the effectiveness of the Neodyne Embrace Advanced Scar Therapy Device treatment?

Research shows that the embrace device, which uses a method called mechanomodulation (a way to reduce stress on healing skin), significantly improves the appearance of scars after surgery. This suggests it could be effective for improving scars in breast reconstruction as well. ^{1 2 3 4 5}

Is the Neodyne Device for Scar Improvement in Breast Reconstruction safe for humans?

There is no specific safety data available for the Neodyne Device for Scar Improvement in Breast Reconstruction in the provided research articles. ^{6 7 8 9 10}

How does the Neodyne Device treatment for scar improvement in breast reconstruction differ from other treatments?

The Neodyne Device is unique because it likely involves a novel mechanism or approach, such as a pressure device or skin expansion, which is different from traditional methods like laser therapy or pharmacotherapy used for scar management. ^{1 11 12 13 14}

Research Team

Arash Momeni, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for women over 18 who've had microsurgical breast reconstruction with abdominal flaps within the last week. They must have a similar scar appearance along the incision, be able to understand and consent to study requirements, and not currently smoke or have certain medical conditions like connective tissue diseases or significant recent weight loss.

Inclusion Criteria

My surgical scar looks the same along its entire length.

Subject has the ability to read and comprehend as required by the protocol and the informed consent

Subject must be able to provide written informed consent prior to participation in the study

Exclusion Criteria

Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus

Subjects who currently smoke

I have been diagnosed with scleroderma.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Application of the Neodyne Device to the abdominal incision for 8 weeks

8 weeks

Weekly visits (in-person) for application and removal of the Neodyne Dressing

Follow-up

Participants are monitored for scar assessment and evaluation

4 months

Visits at 12 weeks and 6 months for scar evaluation

Long-term follow-up

Optional photographic evaluations at 12 months post-surgery

12 months

Treatment Details

Interventions

• Neodyne embrace device (Other)

Trial Overview The trial is testing the Neodyne embrace device's effectiveness on improving the appearance of abdominal scars after breast reconstruction surgery. It's a randomized controlled trial (RCT), which means participants are randomly assigned to receive either the embrace device treatment or no treatment for comparison.

Participant Groups

Group I: Neodyne Device Experimental Treatment 1 Intervention

After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.

Group II: Control Experimental Treatment 1 Intervention

See above

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

A new custom-made pressure device was successfully used as an adjuvant therapy for auricular keloids in a study involving 7 patients, all of whom tolerated the treatment well without any interruptions.

After 24 months of follow-up, there were no recurrences of keloids, indicating that the pressure device may enhance the effectiveness of standard treatments like surgical excision and corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular keloids: combined therapy with a new pressure device. Bran, GM., Brom, J., Hörmann, K., et al.[2022]

The study involving 30 participants showed that using an 810-nm diode laser immediately after surgery significantly improved the appearance of surgical scars, with a 72.73% improvement reported by surgeons in the high-dose group after 12 months.

Higher laser doses (80-130 J/cm²) resulted in better scar outcomes, while lower doses (<80 J/cm²) did not show significant differences compared to untreated scars, highlighting the importance of dose control in laser treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scar prevention using Laser-Assisted Skin Healing (LASH) in plastic surgery. Capon, A., Iarmarcovai, G., Gonnelli, D., et al.[2015]

Laser therapy, particularly fractional lasers, plays a crucial role in scar treatment by normalizing both the appearance and structure of scars, enhancing the overall effectiveness of scar rehabilitation.

Combining laser treatments with other methods like surgery and physical therapy leads to significant improvements in scar management while minimizing patient discomfort and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends and future considerations in scar treatment. Waibel, JS., Rudnick, A.[2019]

A study involving 12 patients showed that using the embrace device after scar revision surgery significantly improved scar appearance, as rated by independent surgeons, with a p-value of less than 0.005.

This research suggests that mechanomodulation techniques, like those used in the embrace device, can effectively enhance aesthetic outcomes in scar management following surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial. Lim, AF., Weintraub, J., Kaplan, EN., et al.[2021]

Nonsurgical methods for scar management include a variety of treatments such as topical applications, intralesional medications, soft-tissue augmentation, and laser therapies, which can be used for prevention, treatment, or as adjuncts to surgical repair.

The 585-nm pulsed dye laser (PDL) is considered the gold standard for treating hypertrophic scars and keloids, while nonablative laser procedures are gaining popularity due to their lower risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers for scars: a review and evidence-based appraisal. Elsaie, ML., Choudhary, S.[2022]

Recent safety research and over 30 years of clinical experience indicate that silicone breast implants are relatively safe, with complication rates comparable to other clean elective surgeries.

While capsular contracture is a known side effect, there is no convincing evidence linking silicone implants to systemic disorders, suggesting that their risk-benefit profile is favorable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the safety of breast implants. Brody, GS.[2019]

High-risk medical devices, while clinically effective, carry inherent hazards that may not be fully understood before they are marketed.

The article emphasizes the importance of evaluating the benefit-risk ratios of these devices through systematic strategies to ensure patient safety and informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical investigations and clinical evaluation strategies. O'Dwyer, J.[2019]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

The shift from autologous tissue to implants for breast reconstruction is influenced by factors like the rise in bilateral mastectomies and improved safety and quality regulations by the FDA, which has led to the approval of various new implant styles since 2012.

Successful prosthetic breast reconstruction relies on careful planning and device selection tailored to individual patient characteristics, ensuring predictable and aesthetically pleasing results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution and update on current devices for prosthetic breast reconstruction. O'Shaughnessy, K.[2020]

A study of 717 delayed breast implant reconstruction procedures found that a history of radiation therapy significantly increases the risk of severe capsular contracture, with hazard ratios of 3.3 for 1-stage and 7.2 for 2-stage procedures.

The risk of reoperation was also higher in patients with a history of radiation therapy, suggesting that alternative reconstruction methods should be considered for these patients, especially since 13.2% of 2-stage procedures failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed breast implant reconstruction: is radiation therapy associated with capsular contracture or reoperations? Hvilsom, GB., Hölmich, LR., Steding-Jessen, M., et al.[2022]

In a study involving nine female patients with contracture of inframammary scars, skin expansion around the breast was successfully used to repair the scars, with eight patients experiencing satisfactory healing and restoration of anatomical positions of the nipples and areola.

Although one patient experienced blood circulation issues at the flap tip requiring skin grafting, the overall results indicate that expanded flaps are a feasible and effective treatment method for this type of scar contracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repair of inframammary scars with expanded skin flaps]. Ma, XJ., Peng, P., Zheng, Y., et al.[2022]

A new two-step technique for treating helical keloids involves placing a kidney-shaped expander to create a blood-rich flap, which is then used to cover the excised area, showing promising results in 12 patients across 16 sites.

Postoperative follow-up of 3 months to 2 years indicated that the reconstructed ears maintained good contour and satisfactory outcomes, suggesting the technique's efficacy in restoring normal skin appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of helical keloid with retroauricular skin expansion]. Zhao, YY., Li, Y., Zeng, XK., et al.[2006]

Excessive scarring from skin injuries affects around 100 million people annually in developed countries, leading to significant physical and psychological impacts, highlighting the need for effective scar management.

The review discusses various treatment approaches, including laser therapy, chemotherapeutic agents, and cryosurgery, with a focus on fractional ablative CO2 laser therapy for burns scars, indicating promising advancements in scar treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers and ancillary treatments for scar management: personal experience over two decades and contextual review of the literature. Part I: Burn scars. McGoldrick, RB., Sawyer, A., Davis, CR., et al.[2020]

Breast reconstruction using a subpectoral silicone tissue expander after modified radical or skin-sparing mastectomy has shown satisfactory results in all cases during a follow-up period of 3 months to 2 years, effectively restoring breast symmetry.

This method allows for sufficient tissue expansion to match the opposite breast, minimizing the need for more invasive surgeries and additional scarring, although caution is advised for patients with previously irradiated chest skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinic applications of primary breast reconstruction with a subpectoral silicone tissue expander]. Zhao, R., Qiao, Q., Zhang, HL.[2006]

References

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

Auricular keloids: combined therapy with a new pressure device. [2022]

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

Scar prevention using Laser-Assisted Skin Healing (LASH) in plastic surgery. [2015]

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

Current trends and future considerations in scar treatment. [2019]

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

The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial. [2021]

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

Lasers for scars: a review and evidence-based appraisal. [2022]

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

On the safety of breast implants. [2019]

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

Clinical investigations and clinical evaluation strategies. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

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

Evolution and update on current devices for prosthetic breast reconstruction. [2020]

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

Delayed breast implant reconstruction: is radiation therapy associated with capsular contracture or reoperations? [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Repair of inframammary scars with expanded skin flaps]. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Treatment of helical keloid with retroauricular skin expansion]. [2006]

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

Lasers and ancillary treatments for scar management: personal experience over two decades and contextual review of the literature. Part I: Burn scars. [2020]

14. China pubmed.ncbi.nlm.nih.gov

[Clinic applications of primary breast reconstruction with a subpectoral silicone tissue expander]. [2006]