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Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser treatment
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fitzpatrick skin type <IV (37),
  • Have sustained a thermal burn injury,
  • Have at least 2 independent sites that show clinical evidence of HSc,
  • Are 2 months or more post-injury.

Exclusion Criteria:

  • Subjects with skin phototypes IV or higher,
  • With history of keloidal scarring,
  • Who have coagulation disorder,
  • Are taking immunosuppressive medications,
  • If the mechanism of injury is an electrical, chemical, or cold injury,
  • Any underlying active skin disease,
  • Have taken oral Isotreinoin within the last 6 months,
  • Photosensitivity or have taken photosensitizing medications,
  • Pregnancy,
  • Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Laser treated HSc scar

    Control scar

    Arm Description

    Co2 laser treatment

    Standard care

    Outcomes

    Primary Outcome Measures

    Skin Characteristics changes
    Erythema, elasticity and thickness measures

    Secondary Outcome Measures

    Satisfaction Questionnaire
    Questionnaire

    Full Information

    First Posted
    February 3, 2017
    Last Updated
    August 15, 2017
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03240718
    Brief Title
    Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
    Official Title
    Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.
    Detailed Description
    Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laser treated HSc scar
    Arm Type
    Experimental
    Arm Description
    Co2 laser treatment
    Arm Title
    Control scar
    Arm Type
    No Intervention
    Arm Description
    Standard care
    Intervention Type
    Procedure
    Intervention Name(s)
    Laser treatment
    Intervention Description
    CORE fractional CO2 laser treatment
    Primary Outcome Measure Information:
    Title
    Skin Characteristics changes
    Description
    Erythema, elasticity and thickness measures
    Time Frame
    baseline, 12 weeks and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Satisfaction Questionnaire
    Description
    Questionnaire
    Time Frame
    baseline, 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fitzpatrick skin type <IV (37), Have sustained a thermal burn injury, Have at least 2 independent sites that show clinical evidence of HSc, Are 2 months or more post-injury. Exclusion Criteria: Subjects with skin phototypes IV or higher, With history of keloidal scarring, Who have coagulation disorder, Are taking immunosuppressive medications, If the mechanism of injury is an electrical, chemical, or cold injury, Any underlying active skin disease, Have taken oral Isotreinoin within the last 6 months, Photosensitivity or have taken photosensitizing medications, Pregnancy, Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bernadette Nedelec, PhD
    Organizational Affiliation
    CRCHUM
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

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