Neodyne Device for Scar Improvement in Breast Reconstruction

Overseen By Shannon Meyer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Steroids

Disqualifiers: Collagen vascular disease, Scleroderma, Smoking, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how well the Neodyne embrace device (a scar therapy device) can improve the appearance of scars after breast reconstruction surgery. It focuses on scars that often widen or thicken due to skin tension. The trial applies the device to one side of the abdominal scar, while the other side receives standard care, allowing for direct comparison. Women who have recently undergone breast reconstruction with abdominal flaps and have similar-looking incisions may be eligible to participate. The aim is to make these scars less noticeable and improve patients' confidence. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance post-surgical recovery and boost self-esteem.

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 prior data suggests that the Neodyne embrace device is safe for scar improvement in breast reconstruction?

Research has shown that the Neodyne embrace device can improve the appearance of scars after surgery. One study found that scars treated with the device looked significantly better after 12 months, suggesting its effectiveness in scar healing.

However, some users have experienced skin issues such as blisters, burning, or rashes after 60 days of use. These side effects suggest that while the device can aid in scar reduction, it may not be suitable for everyone.

Overall, the Neodyne embrace device seems effective in reducing scarring, but users should be aware of potential skin reactions. It is important to consult a doctor if any side effects occur. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neodyne embrace device because it offers a new approach to improving scars after breast reconstruction. Unlike traditional scar treatments that often include topical creams or silicone gel sheets, this device uses a unique application method directly to the incision site. The Neodyne device is designed to apply controlled tension relief, which could promote better healing and reduce scar formation more effectively. This innovative mechanism of action gives hope for more aesthetically pleasing outcomes, potentially changing the standard approach to post-surgical scar care.

What evidence suggests that the Neodyne embrace device is effective for improving abdominal scar appearance in breast reconstruction?

Research has shown that the Neodyne embrace device can significantly improve scar appearance. In this trial, one side of the abdominal incision will receive treatment with the Neodyne Device, while the other side will serve as a control and receive the investigator's standard care. A study found that scars treated with the embrace device appeared better overall after 12 months. The device reduces tension on the scar, preventing it from widening or thickening. This method has shown promising results in both animal studies and early human tests. Overall, the embrace device has effectively reduced scarring in several controlled trials. ^{1 2 4 6 7}

Who Is on the Research Team?

Arash Momeni, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Neodyne embrace device

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4425293/

A Randomized Controlled Trial of the embrace Advanced ... Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and ...

2. withpower.com withpower.com/trial/phase-breast-reconstruction-5-2022-58a16

Neodyne Device for Scar Improvement in Breast ... This trial is testing a special device called the Neodyne embrace to see if it can make scars look better after breast reconstruction surgery.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05377723

Abdominal Scar Improvement in Microsurgical Breast ... Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4874339/

The embrace Device Significantly Decreases Scarring ... Mechanically offloading or shielding an incision significantly reduces scarring in both animal and first-in-human studies. Whether or not this strategy ...

5. embracescartherapy.com embracescartherapy.com/doctors/clinical-data?srsltid=AfmBOorG5q7hR7MNobGaKf1F8upoMiqZ9kO1tLx-WL-hCQZBxAZCa8hx

Clinical Trial Results for embrace® Active Scar Defense The embrace ® Device Significantly Decreases Scarring Following Scar Revision Surgery in a Randomized Controlled Trial. Plast Reconstr Surg. 2014;133:398-405.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05377723

Abdominal Scar Improvement in Microsurgical Breast ... Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9271670&pc=MDA

NEODYNE BIOSCIENCES, INC. EMBRACE SCAR THERAPY After my first application (60 days are recommended) i noticed blistering, burning, rashes, and even chunks of my skin that had peeled off onto the silicone ...