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Clinical Trials/NCT01773447
NCT01773447
Completed
Not Applicable

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

University of California, Davis1 site in 1 country47 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Basal Cell Carcinoma
Sponsor
University of California, Davis
Enrollment
47
Locations
1
Primary Endpoint
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
April 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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