Linear Cutaneous Wound Clinical Trial
Official title:
Use of Embrace Device After Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
NCT number | NCT03294863 |
Other study ID # | 101077 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2017 |
Est. completion date | March 2028 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 2028 |
Est. primary completion date | March 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis, Department of Dermatology | Sacramento | California |
United States | University of California, Davis, Department of Dermatology | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Primary | 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 | 3 months |