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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Embrace Scar Therapy Device treatment for scarring after wound closure?

A study on tension offloading, similar to the Embrace Scar Therapy Device, showed that using this method on an Achilles tendon repair incision resulted in a flatter and less pigmented scar compared to untreated areas, suggesting its potential effectiveness in improving scar appearance. ^{1 2 3 4 5}

How is the Embrace Scar Therapy Device treatment different from other scar treatments?

The Embrace Scar Therapy Device is unique because it is specifically designed to apply gentle pressure to the skin, which can help minimize scar formation by reducing tension on the wound. This approach differs from other treatments like lasers or silicone gels, which focus on altering the skin's healing process or providing a protective barrier. ^{1 2 6 7 8}

Research Team

Daniel B Eisen, MD

Principal Investigator

UC Davis

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

References

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

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

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

Clinical Observation of Sequential Laser Therapy Combined with Tension Reducer for Postoperative Tension Incision Scar Growth. [2023]

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

A 1-Year Follow-Up of Post-operative Scars After the Use of a 1210-nm Laser-Assisted Skin Healing (LASH) Technology: A Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Tension offloading improves cutaneous scar formation in Achilles tendon repair. [2022]

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

Scars: a review of emerging and currently available therapies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Laser-assisted skin healing (LASH) in hypertrophic scar revision. [2015]

7. 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]

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

Exploiting the viscoelastic properties of pedal skin with the Sure Closure skin stretching device. [2012]