Fractional Ablative Laser Treatment for Skin Grafts

Wake Forest University (WFU)

Status: Completed

Conditions: Skin Graft Scar; Burn Scar

Treatments: Device: Fractional Ablative Laser; Drug: Lidocaine Cream; Drug: Triamcinolone Acetonide Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04176705

IRB00058363

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups, including a placebo group

Laser

Experimental group

Description:

Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.

Treatment:

Drug: Triamcinolone Acetonide Cream

Drug: Lidocaine Cream

Device: Fractional Ablative Laser

No laser

Placebo Comparator group

Description:

Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.

Treatment:

Drug: Triamcinolone Acetonide Cream

Drug: Lidocaine Cream