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Completed

NCT Number: NCT02550574

Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.

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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 cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. Our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years of age
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
  • 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
  • Patients on systemic steroid therapies
  • Patients with Marfans
  • Patients with allergies to 2-octylcyanoacrylate

Treatment and study plan

Wound Closure with 2-octylcyanoacrylate

Procedure

Wound Closure with 5-0 Vicryl Sutures

Procedure

Primary outcomes

  1. Appearance 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 vicryl sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.

Secondary outcomes

  1. Incidence of Graft Failure on Case Report

    Time frame: 3 months

    The secondary endpoint will include incidence of graft failure (partial and complete on both sides).

  2. Incidence of Complications on Case Report

    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) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Jun 21, 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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