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Set-back Suture Versus Traditional Vertical Mattress Suture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01773447
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : March 31, 2017
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Squamous Cell Carcinoma Melanoma Procedure: Set-back suture Procedure: Vertical mattress suture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
Official Title: Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
Study Start Date : August 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Set-back suture
Wound to be close by set-back suture technique.
Procedure: Set-back suture
Active Comparator: Vertical mattress suture technique
Wound to be closed by vertical mattress technique.
Procedure: Vertical mattress suture

Primary Outcome Measures :
  1. 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.

  2. Scar width [ Time Frame: 3 months ]
    Width of scar in millimeters for each side of scar measured 1 cm from the midline.

Secondary Outcome Measures :
  1. Height of scar immediately following wound closure [ Time Frame: 5 minutes ]
    Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01773447

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United States, California
UC Davis, Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Daniel Eisen, M.D. University of California, Davis

Additional Information:
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Responsible Party: University of California, Davis Identifier: NCT01773447    
Other Study ID Numbers: 247354
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell