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Purpose

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥ 18 years of age - At least 1 second or third degree burn wound that required treatment with split-thickness skin grafts - Donor site with at least a 4 x 4 inch surface area - Able to return to clinical site for treatments and assessments of burn injuries

Exclusion Criteria

  • Pregnancy or nursing - Oral retinoid medication use within the past 6 months - Medical history of Ehlers-Danlos syndrome, AIDS - Nutritional deficiencies in the opinion of the investigator that would affect wound healing - Wounds complicated by clinically significant infection within past 30 days

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Intra-subject comparison
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of Care 		Scar section does not receive CO2 laser therapy.
Experimental
Factional CO2 		Scar section receives fractional CO2 laser therapy.
  • Procedure: Fractional CO2 Laser
    The UltraPulse® fractional ablative CO2 Laser will be employed with the DeepFX™ hand piece. Number of passes and laser settings, including fluency, density, spot size, will be chosen during the time of treatment as determined by the operating surgeon.

More Details

Status
Active, not recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.