Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial
Stopped: Due to staff shortages we are closing the study.
0Started 2016-12
Plain-language 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.
Who can participate
Age range6 Months – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 compromi…
What they're measuring
1
Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit