Set-back Suture Versus Traditional Vertical Mattress Suture

This study has been completed.
Information provided by (Responsible Party):
Daniel Eisen, MD, University of California, Davis Identifier:
First received: January 15, 2013
Last updated: June 18, 2014
Last verified: June 2014
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 Intervention
Basal Cell Carcinoma
Squamous Cell Carcinoma
Procedure: Set-back suture
Procedure: Vertical mattress suture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Mean of sum of 2 blinded reviewers Physician Observer Assessment scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Width of scar in millimeters for each side of scar measured 1 cm from the midline.

Secondary Outcome Measures:
  • Height of scar immediately following wound closure [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters

Estimated Enrollment: 47
Study Start Date: August 2011
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
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Please refer to this study by its identifier: NCT01773447

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

Responsible Party: Daniel Eisen, MD, Associate Professor of Clinical Dermatology, University of California, Davis Identifier: NCT01773447     History of Changes
Other Study ID Numbers: 247354 
Study First Received: January 15, 2013
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell processed this record on May 26, 2016