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Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG (Er:YAG)

Primary Purpose

Post-Surgical Scars

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Er:YAG laser, traditional and fractional settings
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Surgical Scars focused on measuring scar, ICD-10 CM:L90.5

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • over 8 weeks s/p scar
  • linear closure
  • visibly symmetric scar
  • over 18 years old

Exclusion Criteria:

  • concomitant treatment of involved skin
  • propensity for keloid scarring
  • use of oral retinoids for the past 1 year
  • pregnancy
  • immunosuppression
  • prior laser to the area

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.

    Outcomes

    Primary Outcome Measures

    Patient Observer Scar Assessment Scale (POSAS)
    It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.

    Secondary Outcome Measures

    Patient Preference
    The number of patients who preferred the fractionated laser

    Full Information

    First Posted
    March 4, 2015
    Last Updated
    July 5, 2017
    Sponsor
    University of Louisville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02397564
    Brief Title
    Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
    Acronym
    Er:YAG
    Official Title
    Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Louisville

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3 months. Then follow up for the next 2 months.
    Detailed Description
    Background: Scars are a common complaint of patients at presentation to a dermatology office. To optimize cosmetic results, the investigators propose to compare erbium-doped yttrium aluminium garnet (Er:YAG) laser therapy on two different settings: traditional ablative versus fractional ablative. A side to side comparison of split scars will be done to evaluate the two settings. Fractionated photothermolysis (fractional setting) has improved the field of laser surgery by allowing the surgery to target microscopic treatment zones (MTZ). MTZ's allow for cylinders of damage created by laser surgery to be surrounded by normal, unaffected skin. This acts as a reservoir for healing and allows for the microwounds created by laser treatment to heal quickly and with minimal discomfort. Objective: To compare efficacy and cosmetic appearance of scars treated with Er:YAG ablative laser on traditional ablative resurfacing setting versus fractional ablative resurfacing setting. Methods: Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment. Pictures of the scar will be taken at a 45 degree and 90 degree angle at baseline, before each treatment, after each treatment, and at all follow up appointments. The patients will be blinded as to which side is treated with which laser setting. At the end of the trial, they will be offered the chance to have the side they felt had less improvement treated with the laser device that had been used on the contralateral side of the scar. Results: A panel of three blinded dermatologists will evaluate the scar on a well-established five point grading scale for erythema, height and texture, and overall cosmetic outcome. The mean, standard deviation, and kappa values will be calculated. Patients will be asked the same scar evaluation questions as the panel as well as their overall satisfaction, how much pain was associated with the procedure, which laser they preferred, and would they recommend treatment to a friend or family member.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Surgical Scars
    Keywords
    scar, ICD-10 CM:L90.5

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Er:YAG laser, traditional and fractional settings
    Intervention Description
    Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting
    Primary Outcome Measure Information:
    Title
    Patient Observer Scar Assessment Scale (POSAS)
    Description
    It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Patient Preference
    Description
    The number of patients who preferred the fractionated laser
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: over 8 weeks s/p scar linear closure visibly symmetric scar over 18 years old Exclusion Criteria: concomitant treatment of involved skin propensity for keloid scarring use of oral retinoids for the past 1 year pregnancy immunosuppression prior laser to the area
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy S Brown, MD
    Organizational Affiliation
    University of Louisville
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG

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