Scar Clinical Trial
Official title:
Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm) From Wound Edge on the Closure of Linear Wounds on the Head and Neck: a Randomized Evaluator Blinded Split Wound Comparative Effective Trial
NCT number | NCT04870008 |
Other study ID # | 1508837 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 20, 2019 |
Est. completion date | April 1, 2021 |
Verified date | April 2021 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is standard teaching that the top layer of sutures should be placed 3-5mm from the wound edge. However, there is lack of data regarding the most optimal placement of sutures from the wound edge for the best cosmetic outcome. The research team wish to determine if sutures placed closer to the wound edge (2mm) or farther from the wound edge (5mm) makes a difference in the cosmetic outcome of the scar.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 1, 2021 |
Est. primary completion date | November 20, 2020 |
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 on the head and neck with predicted primary closure - Willing to return for follow up visit Exclusion Criteria: - Mentally handicapped - Incarceration - Under 18 years of age - Pregnant Women - Wounds with predicted closure length less than 3 cm |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The score of two blinded reviewers using the patient observer scar assessment score | At the follow-up visit, two blinded observers will record their scores independently using the POSAS (Patient and Observer Scar Assessment Scale) instrument. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation). The total score of both scales can be simply calculated by summing up the scores of each of the six items. | 3-12 months | |
Primary | The mean scar width using the trace-to-tape method at the assessment visit | The trace-to-tape method is an objective outcome measure for linear postoperative scars. Mean scar width in mm. | 3-12 months | |
Secondary | Any complications from the treatment | Occurrence of any complications including: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma | 3-12 months |
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