Clinical Trial: Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit [ Time Frame: Baseline and 3 months ]

Original Primary Outcome: Change in Hypotrophic scar score on the VSS from baseline to three month visit [ Time Frame: Three months ]

Current Secondary Outcome: Long-term hypotrophic scar score on VSS [ Time Frame: Two years ]

Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: November 12, 2014
Date Started: December 2016
Date Completion: December 2017
Last Updated: April 13, 2017
Last Verified: April 2017