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

April 13, 2017 updated by: University of North Carolina, Chapel Hill

Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial: The Sequential Multiple Assignment Randomized Trial (SMART) Approach to Treatment of Hypertrophic Burn Scars

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CO2-CO2-Med
Participants will receive two blocks of CO2 laser treatment, followed by one block of usual care.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Active Comparator: Med-CO2-CO2
Participants will receive one block of usual care, followed by two blocks of CO2 laser therapy.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Active Comparator: PDL-PDL-MED
Participants will receive two blocks of PDL laser therapy, followed by one block of usual care.
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: Med-PDL-PDL
Participants will receive one block of usual care, followed by two blocks of PDL laser therapy.
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
Active Comparator: 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.
Procedure: CO2 laser treatment
Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
Other: Usual care
Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
Procedure: PDL laser treatment
Surgical treatment using flashlamp-excited pulsed dye laser (PDL)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit
Time Frame: Baseline and 3 months
Baseline and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Long-term hypotrophic scar score on VSS
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Hultman, MD, UNC-Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-0735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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