Surgery Clinical Trial
Official title:
Comparison of Cosmetic Outcomes of Straight Line and W-plasty Techniques for Linear Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Verified date | September 2021 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the cosmetic outcome of traditional straight-line (SL) linear closure to that of W plasty (a type of geometric broken-line cutaneous closure technique) for closure of post-auricular wounds resulting from harvest of full thickness skin grafts during Mohs micrographic surgery. The research team will use a split wound model, where half of the wound is repaired with a straight-line cutaneous closure and the other half is repaired with the W-plasty technique. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale (POSAS), a validated scar instrument. The scar width, and adverse events will also be recorded.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 1, 2021 |
Est. primary completion date | August 31, 2021 |
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 or face for which a full thickness skin graft will be used as part of the reconstruction or has a lesion that will be excised in mastoid area of the neck, behind the ear. - Willing to return for follow up visit. Exclusion Criteria: - Wounds predicted to be less than 3 cm in size after closure. - Unable to understand written and oral English - Incarceration - Under 18 years of age - Pregnant Women |
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 | Patient Observer Scar Assessment Scale (POSAS) scores | The primary outcome is the difference in Patient Observer Scar Assessment Scale (POSAS) scores between the halves of the wound (standard linear closure versus W-plasty). The POSAS instrument incorporates separate questionnaires for observers and patients. Each questionnaire contains six items with possible scores from 0-10 for a total maximum score of 60 on each component (patient and observer). | 3-12 months |
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