Study Stopped
Due to staff shortages we are closing the study.
Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial
LIBERTI
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 17, 2017
April 1, 2017
1 year
November 12, 2014
April 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit
Baseline and 3 months
Secondary Outcomes (1)
Long-term hypotrophic scar score on VSS
Two years
Study Arms (12)
CO2-CO2-Med
ACTIVE COMPARATORParticipants will receive two blocks of CO2 laser treatment, followed by one block of usual care.
Med-CO2-CO2
ACTIVE COMPARATORParticipants will receive one block of usual care, followed by two blocks of CO2 laser therapy.
CO2-Med-CO2
ACTIVE COMPARATORParticipants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy.
PDL-PDL-MED
ACTIVE COMPARATORParticipants will receive two blocks of PDL laser therapy, followed by one block of usual care.
Med-PDL-PDL
ACTIVE COMPARATORParticipants will receive one block of usual care, followed by two blocks of PDL laser therapy.
PDL-Med-PDL
ACTIVE COMPARATORParticipants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.
PDL-CO2-Med
ACTIVE COMPARATORParticipants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care.
CO2-PDL-Med
ACTIVE COMPARATORParticipants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care.
Med-PDL-CO2
ACTIVE COMPARATORParticipants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy.
Med-CO2-PDL
ACTIVE COMPARATORParticipants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy.
PDL-Med-CO2
ACTIVE COMPARATORParticipants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy.
CO2-Med-PDL
ACTIVE COMPARATORParticipants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy.
Interventions
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Hultman, MD
UNC-Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2014
First Posted
January 13, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 17, 2017
Record last verified: 2017-04