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Embrace Scar Therapy Device for Scarring After Wound Closure

N/A

Waitlist Available

Led By Daniel B Eisen, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Patient scheduled for cutaneous surgical procedure along a flat surface suitable to application of the embrace with predicted primary closure

Able to apply dressings themselves

Must not have

Unable to understand written and oral English

Wounds with predicted closure length less than 3 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Summary

This trial is testing whether a device that applies pressure to surgery wounds can improve the appearance of scars.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to the adhesive used by the Embrace device such as skin irritation or an allergic response.

Eligibility Criteria

Inclusion Criteria

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

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

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I can apply dressings by myself.

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I am 18 years old or older.

Exclusion Criteria

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

Select...

I cannot understand written or spoken English.

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My wound is expected to close and is less than 3 cm long.

Select...

I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Physician observer scar assessment score (POSAS)

Width of the scar

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Embrace Scar Therapy DeviceExperimental Treatment1 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 CarePlacebo Group1 Intervention

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

0 / 6Eligibility criteria met