What side effects are associated with this type of intervention?

Common treatments for scar improvement, such as silicone sheets, pressure therapy, laser therapy, and injectable fillers, have various side effects. Silicone sheets and pressure therapy are generally well-tolerated but can cause skin irritation and discomfort. Laser therapy, while effective, may lead to temporary redness, swelling, and in some cases, changes in skin pigmentation. Injectable fillers can cause bruising, swelling, and the formation of nodules or granulomas. These side effects are usually mild and temporary but should be discussed with a healthcare provider.

What prior FDA approvals exist?

The Neodyne embrace device, which reduces tension across the incision to improve scar appearance, is being studied in a novel RCT for its effectiveness in microsurgical breast reconstruction. While specific FDA approvals for similar devices are not detailed in the provided context, treatments that reduce mechanical tension on scars, such as silicone sheets and gels, have been commonly used and are FDA-approved for improving scar appearance. These treatments work by hydrating the scar tissue and reducing tension, which can help in flattening and softening the scar.

What other types of research exist?

Promising, novel alternatives to the Neodyne embrace device for improving scar appearance include: 1) Intense Pulsed Light (IPL) therapy, which has shown effectiveness in treating various skin conditions and improving scar appearance. 2) Injectable soft tissue fillers, such as hyaluronic acid, which can help in reducing the visibility of scars by adding volume and improving skin texture. 3) Photodynamic therapy (PDT), which combines light and photosensitizing agents to target and improve scar tissue. 4) Nonablative skin resurfacing techniques, such as picosecond lasers, which can enhance skin rejuvenation and reduce scar appearance.

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Neodyne Device for Scar Improvement in Breast Reconstruction

N/A

Recruiting

Led By Arash Momeni, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18

Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation

Must not have

Subjects diagnosed with scleroderma

Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin reactions related to sensitivity towards steri-strip tapes, medical tapes, or adhesives used in conjunction with the Neodyne embrace device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I had breast reconstruction with tissue from my abdomen about a week ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with scleroderma.

Select...

My surgical wound is not fully healed and is leaking.

Select...

I have lost more than 100 lbs in the last 6 months before my surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Scar Assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Neodyne DeviceExperimental Treatment1 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: ControlExperimental Treatment1 Intervention

See above

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for scars, such as the Neodyne embrace device, work by reducing mechanical tension across the incision, which helps prevent scar widening and hypertrophy. This is crucial for scar patients as it can significantly improve the cosmetic appearance of scars. Other treatments, like nonablative fractional laser therapy, promote collagen remodeling by heating the dermis, leading to collagen contraction and new collagen formation. These mechanisms are important because they address both the structural and aesthetic aspects of scar healing, providing patients with better overall outcomes.

Laser therapy for treating hypertrophic and keloid scars.