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Comparison of Fast-Absorbing Sutures for Mohs Surgery

Primary Purpose

Cicatrix

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Surgical wound closure with superficial absorbable sutures
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Suture Comparison

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are over 18 years and are having Mohs surgery on the face.

Exclusion Criteria:

  • Patients with surgical wounds less than 4cm in length
  • Patients requiring full thickness skin grafts for reconstruction
  • Patients who are unable to attend routine postoperative follow-up appointments
  • Patients who are receiving radiation therapy after surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Absorbable suture closure

    Arm Description

    Patients will have half of their surgical wound closed using one kind of absorbable superficial sutures, and the other half with a different kind of absorbable superficial suture. Which half receives which suture will be randomly determined.

    Outcomes

    Primary Outcome Measures

    The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
    In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
    The Wound Evaluation Scale (WES) score (cosmetic outcome)
    In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
    The Visual Analogue Scale (VAS) score (cosmetic outcome)
    In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2014
    Last Updated
    January 6, 2015
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02334917
    Brief Title
    Comparison of Fast-Absorbing Sutures for Mohs Surgery
    Official Title
    Comparison of Fast-Absorbing Sutures for Mohs Surgery Repair on the Face (ComFAS): a Randomized Controlled Split-scar Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    June 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is being carried out to assess equivalence of scar outcome for two absorbable sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there is no evidence indicating if any of the sutures above allow for a better cosmetic outcome (less erythema, edema, and scarring).
    Detailed Description
    Prospective randomized controlled split-scar observer-blinded study. After dermatologic surgery on the face, surgeons have a choice between using non-absorbable or absorbable sutures for skin closure. A dermatologic surgeon favoring absorbable sutures for wound closure will consider many factors in material selection, including ease of manipulation, cost, and absorption time. However, there have been no randomized trials comparing the most important measure: aesthetic/cosmetic outcome. Study endpoint/outcome: use three validated scar assessment tools.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cicatrix
    Keywords
    Suture Comparison

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Absorbable suture closure
    Arm Type
    Experimental
    Arm Description
    Patients will have half of their surgical wound closed using one kind of absorbable superficial sutures, and the other half with a different kind of absorbable superficial suture. Which half receives which suture will be randomly determined.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical wound closure with superficial absorbable sutures
    Intervention Description
    Different superficial absorbable sutures will be used in the closure of skin wounds after Mohs surgery. No drugs or devices are being compared, only the two different absorbable sutures (Vicryl Rapide and Fast Absorbing Gut).
    Primary Outcome Measure Information:
    Title
    The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
    Description
    In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
    Time Frame
    6 months
    Title
    The Wound Evaluation Scale (WES) score (cosmetic outcome)
    Description
    In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
    Time Frame
    6 months
    Title
    The Visual Analogue Scale (VAS) score (cosmetic outcome)
    Description
    In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who are over 18 years and are having Mohs surgery on the face. Exclusion Criteria: Patients with surgical wounds less than 4cm in length Patients requiring full thickness skin grafts for reconstruction Patients who are unable to attend routine postoperative follow-up appointments Patients who are receiving radiation therapy after surgery.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David M Zloty, MD
    Email
    david.zloty@vch.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luiz C Pantalena, MD, PhD
    Email
    luiz.pantalena@vch.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David M Zloty, MD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Fast-Absorbing Sutures for Mohs Surgery

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