Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial
NCT ID: NCT02655211
Last Updated: 2017-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CO2-CO2-Med
Participants will receive two blocks of CO2 laser treatment, followed by one block of usual care.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Med-CO2-CO2
Participants will receive one block of usual care, followed by two blocks of CO2 laser therapy.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
CO2-Med-CO2
Participants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
PDL-PDL-MED
Participants will receive two blocks of PDL laser therapy, followed by one block of usual care.
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Med-PDL-PDL
Participants will receive one block of usual care, followed by two blocks of PDL laser therapy.
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
PDL-Med-PDL
Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
PDL-CO2-Med
Participants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
CO2-PDL-Med
Participants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Med-PDL-CO2
Participants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Med-CO2-PDL
Participants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
PDL-Med-CO2
Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
CO2-Med-PDL
Participants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.
CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Interventions
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CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
99 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Scott Hultman, MD
Role: PRINCIPAL_INVESTIGATOR
UNC-Chapel Hill
Other Identifiers
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13-0735
Identifier Type: -
Identifier Source: org_study_id
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