Set-back Suture Versus Traditional Vertical Mattress Suture

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques

Conditions
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Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma

Intervention / Treatment
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* Procedure: Set-back suture
* Procedure: Vertical mattress suture


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Set-back suture<br>Wound to be close by set-back suture technique. | Procedure: Set-back suture<br> <br> |
| Active Comparator: Vertical mattress suture technique<br>Wound to be closed by vertical mattress technique. | Procedure: Vertical mattress suture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of sum of 2 blinded reviewers Physician Observer Assessment scores | 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. | 3 months | 
| Scar width | Width of scar in millimeters for each side of scar measured 1 cm from the midline. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height of scar immediately following wound closure | Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters | 5 minutes |