Set-back Suture Versus Traditional Vertical Mattress Suture

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniel Eisen, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01773447
First received: January 15, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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
Melanoma
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

Resource links provided by NLM:


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 ]
    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
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773447

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

No publications provided

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 21, 2014