Clinical trial NCT04176705: Fractional Ablative Laser Treatment for Skin Grafts
Official title: Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scar
Skin Graft Scar
Keywords: Fractional laser
Ablative Laser
Carbon Dioxide Laser
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Doctors and patients refer to all areas of skin changes from burn injury as burn scars. However, different areas of scars from burns can be treated differently. The burn scars that come from skin grafting surgery might be improved with laser treatment. The purpose of this study is to see if treating burn skin graft scars with a laser could make it better.

Fractional Ablative Laser has been approved by the US Food and Drug Administration (FDA), but it has not been approved for use in the early stages of scar maturation and is considered investigational for this study.

Detailed description: This pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. The study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the Fractional Carbon Dioxide (FxCO2) laser and have significantly less secondary contracture than control sites. The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. The current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. Preliminary work completed by our team has confirmed that the red Duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the FxCO2 on split-thickness skin grafts decreased secondary contracture. Further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. The study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. In these patients who had larger burn returning to the OR for additional procedures, the study team was able to offer FxCO2 treatment as a "salvage" therapy. With this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. The study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) FxCO2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.

Eligibility criteria: Inclusion Criteria:

* Patients who are to undergo skin grafting procedures for acute treatment of thermal burns.
* Patients with grafts placed over at least 100cm\^2

Exclusion Criteria:

* Patients who have are not scheduled to undergo skin grafting procedures
* Patients who have grafts placed under 100cm\^2

Primary outcomes:
measure: Contracture of Scar Surface Area (Percentage of Original Area)
timeFrame: 90 days post-grafting
measure: Contracture of Scar Surface Area (Percentage of Original Area)
timeFrame: 1 year post-grafting
Secondary outcomes:
measure: Scar Roughness
timeFrame: 90 days post-grafting
measure: Scar Roughness
timeFrame: 1 year post-grafting
measure: Biomechanics Stiffness
timeFrame: 90 days post-grafting
measure: Biomechanics Stiffness
timeFrame: 1 year post-grafting
measure: Biomechanics Elasticity
timeFrame: 90 days post-grafting
measure: Biomechanics Elasticity
timeFrame: 1 year post-grafting
measure: Erythema Index
timeFrame: 90 days post-grafting
measure: Erythema Index
timeFrame: 1 year post-grafting
measure: Vancouver Scar Scale (VSS)
timeFrame: 90 days post-grafting
measure: Vancouver Scar Scale (VSS)
timeFrame: 1 year post-grafting
measure: Patient and Observer Scar Assessment Scale (POSAS)--Patient
timeFrame: 90 days post-grafting
measure: Patient and Observer Scar Assessment Scale (POSAS)--Observer
timeFrame: 90 days post-grafting
measure: Patient and Observer Scar Assessment Scale (POSAS)--Patient
timeFrame: 1 year post-grafting
measure: Patient and Observer Scar Assessment Scale (POSAS)--Observer
timeFrame: 1 year post-grafting
measure: Patient-Reported Satisfaction
timeFrame: 90 days post-grafting
measure: Patient-Reported Satisfaction
timeFrame: 1 year post-grafting
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: