Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Study Overview
Brief Summary
The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elliptical surgical wound that needs to be closed with a layered closure
- •Wound 3 cm in length or longer
Exclusion Criteria
- •Incarceration
- •Active pregnancy
- •Less than 18 years of age
- •Unable to give informed consent
- •Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
- •Wound closure projected to be less than 3 cm in length
- •Skin less than 3 mm in thickness (dermis and epidermis combined)
Outcomes
Primary Outcomes
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Time Frame: 3 months
Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows: a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.
Scar width
Time Frame: 3 months
Width of scar in millimeters for each side of scar measured 1 cm from the midline.
Secondary Outcomes
- Height of scar immediately following wound closure(5 minutes)