Post Excision/Mohs Scar Laser Resurfacing
- Conditions
- Skin Cancer
- Interventions
- Device: Laser Treatment
- Registration Number
- NCT02130297
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and aged >18 years at the time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Patients undergoing skin excisions of the face/trunk/extremities.
- Inability to provide voluntary informed consent
- Use of laser or light based treatments to affected areas in past year
- Fitzpatrick Skin types 3-5
- Surgical lesions located on the central chest
- History of keloid formation
- History of Accutane in the last six months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 - day 1 Laser Treatment Group 1 will receive laser therapy to half of the scar the day of the excision. Group 3 - week 9 Laser Treatment Group 3 will receive laser treatment to half the scar at the 9 week postop visit. Group 2 - day 14 Laser Treatment Group 2 will receive laser therapy at the time of suture removal or post-operative day 14.
- Primary Outcome Measures
Name Time Method MMSS for Scar Halves Treated Day 0 and Day 14 modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes
- Secondary Outcome Measures
Name Time Method Quartile Scale 24 weeks post-op 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.
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity Day 0 and Day 14 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.
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States