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Set-back Suture Versus Traditional Vertical Mattress Suture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01773447
First received: January 15, 2013
Last updated: March 29, 2017
Last verified: March 2017
  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
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

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 ]

    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 ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01773447     History of Changes
Other Study ID Numbers: 247354
Study First Received: January 15, 2013
Last Updated: March 29, 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on August 18, 2017