The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar.
The objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative CO2 laser improves both the texture and cosmetic appearance of the scar. An attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. In order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. In addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser. There will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. Each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. Healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
The subject will receive ablative fractional resurfacing with the Deep and Active FXTM platforms of the Lumenis Ultrapulse CO2 laser. The settings for treatment of scars on the face with the Deep platform will be 15% coverage, 15mJ at 150 Hz and 15% coverage, 12.5 mJ at 150 Hz for off the face. The Active platform settings will be 90 mJ with a density of 3 for the face and 70 mJ and a density of 2 for off the face. The DeepFXTM platform will be applied to the scar prior to the ActiveFX TM platform. Half of the excision scar will be treated with the appropriate settings and half will go untreated.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
MMSS for Scar Halves Treated
modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes
Time frame: Day 0 and Day 14
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity
Fd indicates scar tissue density - a measure of how completely an object fills space and increases in value with increasing structural density. It has a value between 1 and 2: a minimum value of 1 corresponds to a straight line filling the space, and a maximum value of 2 corresponds to an object completely occupying the entire space. Lacunarity describes the characteristics of fractals of the same dimension with different texture appearances and indicates scar tissue architecture (homogeneous vs. heterogeneous) - a measure of the nonuniformity (heterogeneity) of a structure or the degree of structural variance within an object. L has a value between 0 and 1, where a minimum value of 0 corresponds to an absolute homogeneous object.
Time frame: Day 0 and Day 14
Quartile Scale
Comparison of scars using quartile scale: 0 indicates no difference, 1 indicates a 1-25% difference or "mild" difference, 2 indicates a 26-50% or moderate difference, 3 indicates a 51-75% or significant improvement and 4 indicates a 76-100% difference or very significant.
Time frame: 24 weeks post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.