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Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial (LIBERTI)

Primary Purpose

Hypertrophic Scars

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CO2 laser treatment
PDL laser treatment
Usual care
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scars

Eligibility Criteria

6 Months - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have a burn injury which will be at least 6 months old at the time of first treatment,
  • have one or more symptomatic burn scars (with at least one or more symptoms such as erythema, pruritus, surface irregularity, or tightness not caused by a contracture that would be better served with surgical treatment),
  • desire laser treatment,
  • be at least 6 months of age at the time of treatment,
  • agree to have no aesthetic treatments for their burn scars, such as peels or fillers, until they have completed the study (two-year period),
  • agree to be randomized into one of the study's treatment conditions,
  • agree to return for all treatment and follow-up visits for the two-year study period,
  • agree to refrain from participating in any other treatment-oriented clinical trial for the duration of this study, and
  • be able and willing to follow the protocol requirements.

Exclusion Criteria:

  • be women who are pregnant or planning to become pregnant during the study,
  • have had any previous laser treatment of their burn scars,
  • have open wounds that are not re-epithelialized in the areas of proposed study treatment,
  • be taking systemic steroids or immunosuppression medication,
  • have a connective tissue disorder,
  • be receiving or planning to receive chemotherapy or radiation during the study,
  • be medically unable to tolerate anesthesia, or
  • have other conditions that in the opinion of the investigators or clinicians may affect participant safety or compromise study objectives.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    CO2-CO2-Med

    Med-CO2-CO2

    CO2-Med-CO2

    PDL-PDL-MED

    Med-PDL-PDL

    PDL-Med-PDL

    PDL-CO2-Med

    CO2-PDL-Med

    Med-PDL-CO2

    Med-CO2-PDL

    PDL-Med-CO2

    CO2-Med-PDL

    Arm Description

    Participants will receive two blocks of CO2 laser treatment, followed by one block of usual care.

    Participants will receive one block of usual care, followed by two blocks of CO2 laser therapy.

    Participants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy.

    Participants will receive two blocks of PDL laser therapy, followed by one block of usual care.

    Participants will receive one block of usual care, followed by two blocks of PDL laser therapy.

    Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.

    Participants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care.

    Participants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care.

    Participants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy.

    Participants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy.

    Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy.

    Participants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.

    Outcomes

    Primary Outcome Measures

    Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit

    Secondary Outcome Measures

    Long-term hypotrophic scar score on VSS

    Full Information

    First Posted
    November 12, 2014
    Last Updated
    April 13, 2017
    Sponsor
    University of North Carolina, Chapel Hill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02655211
    Brief Title
    Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial
    Acronym
    LIBERTI
    Official Title
    Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial: The Sequential Multiple Assignment Randomized Trial (SMART) Approach to Treatment of Hypertrophic Burn Scars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to staff shortages we are closing the study.
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of North Carolina, Chapel Hill

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.
    Detailed Description
    The investigator will compare usual care (MED), which will be offered to all patients, to two types of laser treatment (PDL and CO2), which the investigators hypothesize to be beneficial. The timing and sequence of therapy will be randomized, but all patients will receive some form of laser treatment. If the investigators simply stopped at the end of Aim 1, the investigators would complete a traditional randomized control trial (RCT), with some patients potentially receiving laser treatment. However, the investigators are interested in determining whether the sequence of laser treatments is beneficial; therefore, the investigators will be employing a sequential multiple assignment randomized trial (SMART) design. Because of the nature of the study and SMART design, the investigators will offer all patients some form of laser therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CO2-CO2-Med
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive two blocks of CO2 laser treatment, followed by one block of usual care.
    Arm Title
    Med-CO2-CO2
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of usual care, followed by two blocks of CO2 laser therapy.
    Arm Title
    CO2-Med-CO2
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy.
    Arm Title
    PDL-PDL-MED
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive two blocks of PDL laser therapy, followed by one block of usual care.
    Arm Title
    Med-PDL-PDL
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of usual care, followed by two blocks of PDL laser therapy.
    Arm Title
    PDL-Med-PDL
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.
    Arm Title
    PDL-CO2-Med
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care.
    Arm Title
    CO2-PDL-Med
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care.
    Arm Title
    Med-PDL-CO2
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy.
    Arm Title
    Med-CO2-PDL
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy.
    Arm Title
    PDL-Med-CO2
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy.
    Arm Title
    CO2-Med-PDL
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    CO2 laser treatment
    Intervention Description
    Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
    Intervention Type
    Procedure
    Intervention Name(s)
    PDL laser treatment
    Intervention Description
    Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
    Primary Outcome Measure Information:
    Title
    Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit
    Time Frame
    Baseline and 3 months
    Secondary Outcome Measure Information:
    Title
    Long-term hypotrophic scar score on VSS
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have a burn injury which will be at least 6 months old at the time of first treatment, have one or more symptomatic burn scars (with at least one or more symptoms such as erythema, pruritus, surface irregularity, or tightness not caused by a contracture that would be better served with surgical treatment), desire laser treatment, be at least 6 months of age at the time of treatment, agree to have no aesthetic treatments for their burn scars, such as peels or fillers, until they have completed the study (two-year period), agree to be randomized into one of the study's treatment conditions, agree to return for all treatment and follow-up visits for the two-year study period, agree to refrain from participating in any other treatment-oriented clinical trial for the duration of this study, and be able and willing to follow the protocol requirements. Exclusion Criteria: be women who are pregnant or planning to become pregnant during the study, have had any previous laser treatment of their burn scars, have open wounds that are not re-epithelialized in the areas of proposed study treatment, be taking systemic steroids or immunosuppression medication, have a connective tissue disorder, be receiving or planning to receive chemotherapy or radiation during the study, be medically unable to tolerate anesthesia, or have other conditions that in the opinion of the investigators or clinicians may affect participant safety or compromise study objectives.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott Hultman, MD
    Organizational Affiliation
    UNC-Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial

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