Embrace Scar Therapy Device for Scarring After Wound Closure

Overseen By Iryna Rybak, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Adhesive reactions, Collagen disease, others

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Embrace Scar Therapy Device, a silicone dressing, can improve the appearance of scars after surgery. Participants will have a silicone dressing applied to half of their wound, with the other half receiving standard care. Ideal candidates are those scheduled for skin surgery with a wound that can be closed along a flat surface and who can apply dressings and return for follow-up visits.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance post-surgical scar care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Embrace Scar Therapy Device is safe for scarring after wound closure?

Research has shown that the Embrace Scar Therapy Device is safe to use. The FDA has approved it, confirming that it meets the safety standards set by the U.S. Food and Drug Administration for its intended purpose. Made with medical-grade silicone, the device is generally safe for all skin types and ages. The silicone contains no extra chemicals or medications, reducing the risk of irritation or allergic reactions. Studies have demonstrated that the device effectively improves the appearance of scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional scar treatments that often involve creams or ointments, the Embrace Scar Therapy Device is a silicone elastomeric dressing that adheres to the skin with a pressure-sensitive adhesive. This innovative approach provides consistent pressure and hydration to the healing wound, which can help minimize scar formation more effectively. Researchers are excited about this treatment because it offers a non-invasive, easy-to-apply alternative that might enhance cosmetic outcomes after wound closure compared to standard care options.

What evidence suggests that the Embrace Scar Therapy Device is effective for improving scar appearance after wound closure?

Research has shown that the Embrace Scar Therapy Device can greatly improve the appearance of scars. In this trial, participants will have one half of their cutaneous wound treated with the Embrace Scar Therapy Device, while the other half will receive standard care. Studies have found that scars treated with this device look much better than those that aren't. In two clinical trials, named IMPROVE and REFINE, the device noticeably reduced the appearance of scars. Both patients and doctors agreed that scars looked better after using the device for 12 months. This silicone dressing works by gently pressing on the skin, helping to prevent scar formation. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel B Eisen, MD

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent, apply dressings themselves, and return for follow-ups. They're scheduled for skin surgery with a wound that's expected to close up right away and is suitable for the Embrace device. It's not for those under 18, incarcerated, allergic to adhesives, pregnant women, mentally handicapped individuals or anyone with collagen vascular disease.

Inclusion Criteria

I am scheduled for a skin surgery that can be closed up right after.

Able to give informed consent themselves

I can apply dressings by myself.

Exclusion Criteria

Patients with known adverse reactions to adhesives

I cannot understand written or spoken English.

Patients with history of collagen vascular disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Repair and Device Application

Participants undergo surgical repair of cutaneous wounds, followed by application of the embrace device to half of the wound

1 day

1 visit (in-person)

Treatment

Participants use the embrace device on half of the wound to assess its effectiveness in improving scar cosmesis

3 months

Follow-up

Participants are monitored for scar cosmesis and adverse events, with scar assessment conducted using the physician observer scar assessment scale

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Embrace Scar Therapy Device

Trial Overview The study tests if the Embrace Scar Therapy Device improves how scars look after surgical wounds heal compared to standard care. Participants will be assigned to use the device or receive regular treatment without it following their skin surgery.

How Is the Trial Designed?

Group I: Embrace Scar Therapy Device Experimental Treatment 1 Intervention

16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive will be applied to 1/2 of the cutaneous wound

Group II: Standard of Care Placebo Group 1 Intervention

Another 1/2 of cutaneous wound will be treated per standard of care

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

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]

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]

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. embracescartherapy.com embracescartherapy.com/doctors/clinical-data?srsltid=AfmBOop1w4p9dw8Vj4nvnqKUjVi7oztSbpACznIecvW50n_gFa-OOKJE

Clinical Trial Results for embrace® Active Scar Defense The embrace device effectively minimized scarring in both the IMPROVE and REFINE clinical trials with a highly significant difference between embrace-treated ...

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

The embrace Device Significantly Decreases Scarring ... Our data strongly support a significant improvement in scar appearance following revision and treatment with the embrace device. To our knowledge, this is the ...

4. trialx.com trialx.com/clinical-trials/listings/245049/effectiveness-of-embrace-scar-therapy-device-after-cutaneous-wound-closure/

Effectiveness of Embrace Scar Therapy Device After ... The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar ...

5. withpower.com withpower.com/trial/phase-wounds-and-injuries-2-2017-956c5

Embrace Scar Therapy Device for Scarring After Wound ... The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar cosmesis. Show ...

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

NEODYNE BIOSCIENCES, INC. EMBRACE SCAR THERAPY I researched about embrace scar therapy and liked that it was fda approved and showed positive results in clinical trials.I asked my plastic surgeon what he ...

7. embracescartherapy.com embracescartherapy.com/faqs?srsltid=AfmBOoq8s9RA9Nuj6tOT6eqidvJ3cmJDzDE9nMYYZLwxrVuygpETBnGx

Scar-Related Questions Answered Here | embrace® FAQs Yes, embrace ® is safe for all ages and skin types. Embrace ® is FDA-cleared and clinically proven to be safe and effective, as shown in our most rigorous Level ...

8. embracescartherapy.com embracescartherapy.com/privacy-and-terms?srsltid=AfmBOorb7405m8wFQrxTuQr9f0eorgM0lQ3zz0snGjdlDCHulHd_KagR

Privacy Policy and Terms & Conditions | embrace® This Privacy Policy is designed to tell you about what information we collect while you visit this Website, how Neodyne uses such information, and how you can ...

9. amazon.com amazon.com/FDA-Cleared-Medical-Grade-Hypertrophic-Treatment-Extra-Large/dp/B07H7TRS8V

Embrace Active Scar Defense for New Scars, FDA-Cleared ... FDA-Cleared Medical-Grade Silicone Scar Sheets for Hypertrophic & Keloid Scar Treatment, 6.3 Inch, Extra-Large, 30-Day Supply

10. embracescartherapy.com embracescartherapy.com/FAQ-embrace-minimize?srsltid=AfmBOop05yfZR7Rw2uzTkM0LxHb8H-kWdfGGjnBJJp0p_w1GUIjk0Fhs

Frequently Asked Questions About embrace MINIMIZE® Yes, embrace MINIMIZE ® is safe for all ages and skin types. The 100% medical-grade silicone has no added chemicals or medications. It is completely safe to use ...