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Post Excision/Mohs Scar Laser Resurfacing

Not Applicable
Completed
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
GroupInterventionDescription
Group 1 - day 1Laser TreatmentGroup 1 will receive laser therapy to half of the scar the day of the excision.
Group 3 - week 9Laser TreatmentGroup 3 will receive laser treatment to half the scar at the 9 week postop visit.
Group 2 - day 14Laser TreatmentGroup 2 will receive laser therapy at the time of suture removal or post-operative day 14.
Primary Outcome Measures
NameTimeMethod
MMSS for Scar Halves TreatedDay 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
NameTimeMethod
Quartile Scale24 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 LacunarityDay 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

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