Effects of Pulsed-Dyed Laser on Scar Formation
The purpose of this study is to identify changes in color, thickness, and stiffness, of scars from skin grafting after burns when treated with a pulsed-dyed laser.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Pulsed-Dyed Laser on Scar Formation|
- Amount of redness of scar [ Time Frame: 4 to 12 months after skin grafting ] [ Designated as safety issue: No ]
- Scar height [ Time Frame: 4-12 months after skin grafting ] [ Designated as safety issue: No ]
- Scar stiffness [ Time Frame: 4-12 months after skin grafting ] [ Designated as safety issue: No ]
- Patient's assessment of cosmetic outcome [ Time Frame: 4-12months after skin grafting ] [ Designated as safety issue: No ]
- Clinical improvement of appearance of scars assessed by subjective scale [ Time Frame: 4-12 months after skin grafting ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Device: Treatment of 1/2 of skin graft with pulsed-dye laser
Pulsed-dyed lasers have been used in the past to treat scars from minor surgery as well as burns. The laser has been used at different times, close to injury or late after injury. Success or failure of the laser has been judged by subjective observer scales.
In this study we will treat the seams of 1/2 of a skin graft with a pulsed-dyed laser, beginning about one month after surgery. We will use objective measures of color (redness on digital pictures), scar volume(via laser scanning), and elasticity(measured by BTC-2000) as well as subjective assessment by an independent observer and the patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852280
|United States, Ohio|
|Shriners Hospitals for Children, Cincinnati|
|Cincinnati, Ohio, United States, 45229-3095|
|Principal Investigator:||John K Bailey, MD||Shriners Hosptials for Children|