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Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

Primary Purpose

Linear Cutaneous Wound

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embrace Scar Therapy Device
Standard of Care
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Linear Cutaneous Wound focused on measuring Scar, Cosmesis, Embrace Device, Split Wound, Wound Closure, Cutaneous Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Able to give informed consent themselves
  • 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.
  • Willing to return for follow up visits.

Exclusion Criteria:

  • Mentally handicapped
  • Unable to understand written and oral English
  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Wounds with predicted closure length less than 3 cm
  • Patients with known adverse reactions to adhesives
  • Patients with history of collagen vascular disease

Sites / Locations

  • University of California, Davis, Department of Dermatology
  • University of California, Davis, Department of DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Embrace Scar Therapy Device

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Physician observer scar assessment score (POSAS)
Comparison of scar cosmesis over area of wound that was treated with the device as compared to area that was not treated with the device.
Width of the scar
The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar

Secondary Outcome Measures

Full Information

First Posted
September 22, 2017
Last Updated
June 12, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03294863
Brief Title
Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure
Official Title
Use of Embrace Device After Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
March 2028 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. We will use a split wound model, half of the wound is treated with the embrace device and the other half is not treated. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width and adverse events will also be recorded. Following the surgical repair of cutaneous wounds, scar formation is inevitable and results in varying degrees of aesthetic and/or functional impairment. Numerous treatment modalities have been employed to treat scars. Carbon dioxide and pulse dye lasers, as well as dermabrasion can reduce erythema and irregular topology of the scar surface1,2. Silicone-based products have also been used to treat post-surgical scars, including gels, sheets, and tape3-5. Intralesional steroids are often injected into to induce flattening of a scar6. More recent research has highlighted the impact of mechanical forces and tension on scar formation. In one report, incisions in both pigs and humans were treated with a tension-shielding device and showed a reduction in scarring7. More recently two clinical trials have been published in the plastic surgery literature showing that the use of the embrace device, a silicone-based dressing designed to minimize wound tension, is effective in improving the aesthetic outcome following scar revision surgery8,9. While these initial studies of the embrace device have promising findings, there are significant drawbacks to both studies including small study population, inclusion of patients seeking scar revision (a select group likely predisposed to poor scar cosmesis and not representative of first-time surgical patients), investigator conflict of interest, and the use of a digital software-based scar assessment tool using patients photos that were not standardized with respect to lighting or distance. Therefore, larger studies in first-time surgical patients with standardized photos for scar assessment are required to validate this potentially promising device for improved scar cosmesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Linear Cutaneous Wound
Keywords
Scar, Cosmesis, Embrace Device, Split Wound, Wound Closure, Cutaneous Wound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Each subject receives both types of interventions upon the same scar in order for comparison.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embrace Scar Therapy Device
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Another 1/2 of cutaneous wound will be treated per standard of care
Intervention Type
Device
Intervention Name(s)
Embrace Scar Therapy Device
Intervention Description
16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Without the embrace Scar Therapy Device
Primary Outcome Measure Information:
Title
Physician observer scar assessment score (POSAS)
Description
Comparison of scar cosmesis over area of wound that was treated with the device as compared to area that was not treated with the device.
Time Frame
3 months
Title
Width of the scar
Description
The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Able to give informed consent themselves 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. Willing to return for follow up visits. Exclusion Criteria: Mentally handicapped Unable to understand written and oral English Incarceration Under 18 years of age Pregnant Women Wounds with predicted closure length less than 3 cm Patients with known adverse reactions to adhesives Patients with history of collagen vascular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel B Eisen, MD
Phone
916-551-2636
Email
dbeisen@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Iryna Rybak, BS
Phone
916-551-2636
Email
irybak@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B Eisen, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
University of California, Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
Phone
916-734-6479
Email
dbeisen@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Iryna Rybak, BS
Phone
916-551-2636
Email
irybak@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

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