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Embrace Scar Therapy Device for Scarring After Wound Closure

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

I can apply dressings by myself.

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,469 Total Patients Enrolled

Daniel B Eisen, MDPrincipal InvestigatorUC Davis

Media Library

Embrace Scar Therapy Device (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03294863 — N/A

Linear Cutaneous Wound Research Study Groups: Standard of Care, Embrace Scar Therapy Device

Linear Cutaneous Wound Clinical Trial 2023: Embrace Scar Therapy Device Highlights & Side Effects. Trial Name: NCT03294863 — N/A

Embrace Scar Therapy Device (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03294863 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can be included in this clinical research?

"Affirmative. According to the details listed on clinicaltrials.gov, this trial is actively seeking enrollees and was initially posted on March 15th 2017 with its most recent update being September 29th 2021. 50 patients are needed from a single medical facility for participation in this study."

Answered by AI

Are any additional patients currently being enrolled in this investigation?

"Affirmative, per clinicaltrials.gov, this research is currently enrolling participants. This trial was first posted on March 15th 2017 and has been recently updated on September 29 2021 for the recruitment of 50 patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

2017. "Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03294863.

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