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OpenTrials
Completed

NCT Number: NCT02547077

Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut.

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Key information

Conditions

Wound Closure Techniques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigators will use a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer.
  • Willing to return for follow-up visits

Exclusion criteria

  • Mentally handicapped
  • Unable to understand written and oral English
  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Wounds with predicted closure length less than 3 cm

Treatment and study plan

Wound Closure with 2-octylcyanoacrylate

Procedure

Wound Closure with 5-0 Fast Absorbing Gut Sutures

Procedure

Primary outcomes

  1. Assessment of Scar on the Patient and Observer Scar Assessment Scale

    Time frame: 3 months

    After surgical procedure, half of the subject's wound will be with 2-octylcyanoacrylate, while the other half is closed 5-0 fast absorbing gut sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.

Secondary outcomes

  1. Measurement of Scar Width

    Time frame: 3 months

    The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.

  2. Assessment of Complications

    Time frame: 3 months

    Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 11, 2015
Registry last updated
May 30, 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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