search
Back to results

Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

Primary Purpose

Wound Closure Techniques

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wound Closure with 2-octylcyanoacrylate
Wound Closure with 5-0 Vicryl Sutures
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wound Closure Techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Wound closure with 2-octylcyanoacrylate

    Wound closure with 5-0 vicryl sutures

    Arm Description

    One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).

    One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures.

    Outcomes

    Primary Outcome Measures

    Appearance of Scar on the Patient and Observer Scar Assessment Scale
    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 Outcome Measures

    Incidence of Graft Failure on Case Report
    The secondary endpoint will include incidence of graft failure (partial and complete on both sides).
    Incidence of Complications on Case Report
    Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

    Full Information

    First Posted
    September 9, 2015
    Last Updated
    June 19, 2017
    Sponsor
    University of California, Davis
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02550574
    Brief Title
    Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts
    Official Title
    Use of 2-octylcyanoacrylate (Dermabond) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Closure Techniques

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Wound closure with 2-octylcyanoacrylate
    Arm Type
    Experimental
    Arm Description
    One side of the patient's wound defect will be assigned to wound closure with 2-octylcyanoacrylate liquid bonding agent).
    Arm Title
    Wound closure with 5-0 vicryl sutures
    Arm Type
    Active Comparator
    Arm Description
    One side of the patient's wound defect will be assigned to wound closure with 5-0 vicryl sutures.
    Intervention Type
    Procedure
    Intervention Name(s)
    Wound Closure with 2-octylcyanoacrylate
    Intervention Type
    Procedure
    Intervention Name(s)
    Wound Closure with 5-0 Vicryl Sutures
    Primary Outcome Measure Information:
    Title
    Appearance of Scar on the Patient and Observer Scar Assessment Scale
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Incidence of Graft Failure on Case Report
    Description
    The secondary endpoint will include incidence of graft failure (partial and complete on both sides).
    Time Frame
    3 months
    Title
    Incidence of Complications on Case Report
    Description
    Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Eisen, M.D.
    Organizational Affiliation
    University of California, Davis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

    We'll reach out to this number within 24 hrs