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Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

Hypertrophic Scar Clinical Trial

Official title:
Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

Clinical Trial Summary

A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04769089
Study type Interventional
Source The Metis Foundation
Contact
Status Completed
Phase N/A
Start date December 19, 2017
Completion date June 24, 2020
View Details
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