NCT02655211

Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypertrophic Scars

Interventions

Type	Name	Description
PROCEDURE	CO2 laser treatment	Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
PROCEDURE	PDL laser treatment	Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
OTHER	Usual care	Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-01-13
• Last updated: 2017-04-17