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Completed

NCT Number: NCT01773447

Set-back Suture Versus Traditional Vertical Mattress Suture

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis, Department of Dermatology

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Set-back suture

Procedure

Vertical mattress suture

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2013
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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