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Undermining During Cutaneous Wound Closure

Primary Purpose

Wound Closure Techniques

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wound Closure with Undermining
Wound Closure without Undermining
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:

  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure with predicted linear closure
  • Willing to return for follow up visits

Exclusion Criteria:

  • Mentally handicapped
  • Incarceration
  • Pregnant Women
  • Wounds with predicted closure length less than 3 cm
  • Wounds with diameter > 3 cm
  • Wounds unable to be fully closed without undermining

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Wound Closure with Undermining

    Wound Closure without Undermining

    Arm Description

    The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.

    One side of the wound will remain un-undermined.

    Outcomes

    Primary Outcome Measures

    Assessment of Scar on the Patient and Observer Scar Assessment Scale
    After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.

    Secondary Outcome Measures

    Measurement of Scar Width
    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.
    Assessment of Complications
    Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

    Full Information

    First Posted
    November 10, 2014
    Last Updated
    July 17, 2017
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02289859
    Brief Title
    Undermining During Cutaneous Wound Closure
    Official Title
    Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (Actual)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    July 2016 (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 undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.
    Detailed Description
    The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining 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 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Wound Closure with Undermining
    Arm Type
    Active Comparator
    Arm Description
    The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
    Arm Title
    Wound Closure without Undermining
    Arm Type
    Active Comparator
    Arm Description
    One side of the wound will remain un-undermined.
    Intervention Type
    Procedure
    Intervention Name(s)
    Wound Closure with Undermining
    Intervention Description
    The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
    Intervention Type
    Procedure
    Intervention Name(s)
    Wound Closure without Undermining
    Intervention Description
    One side of the wound will remain un-undermined.
    Primary Outcome Measure Information:
    Title
    Assessment of Scar on the Patient and Observer Scar Assessment Scale
    Description
    After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. 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
    Measurement of Scar Width
    Description
    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.
    Time Frame
    3 months
    Title
    Assessment of Complications
    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: Able to give informed consent themselves Patient scheduled for cutaneous surgical procedure with predicted linear closure Willing to return for follow up visits Exclusion Criteria: Mentally handicapped Incarceration Pregnant Women Wounds with predicted closure length less than 3 cm Wounds with diameter > 3 cm Wounds unable to be fully closed without undermining
    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

    Citations:
    PubMed Identifier
    34546436
    Citation
    Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.
    Results Reference
    derived
    Links:
    URL
    http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
    Description
    University of California-Davis Department of Dermatology Clinical Research

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