Post Excision/Mohs Scar Laser Resurfacing
Primary Purpose
Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Treatment
Sponsored by
About this trial
This is an interventional other trial for Skin Cancer focused on measuring Mohs, scar, post excision, CO2 laser, laser, skin cancer, resurfacing
Eligibility Criteria
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1 - day 1
Group 2 - day 14
Group 3 - week 9
Arm Description
Group 1 will receive laser therapy to half of the scar the day of the excision.
Group 2 will receive laser therapy at the time of suture removal or post-operative day 14.
Group 3 will receive laser treatment to half the scar at the 9 week postop visit.
Outcomes
Primary Outcome Measures
MMSS for Scar Halves Treated
modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02130297
First Posted
April 29, 2014
Last Updated
March 18, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02130297
Brief Title
Post Excision/Mohs Scar Laser Resurfacing
Official Title
Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Mohs, scar, post excision, CO2 laser, laser, skin cancer, resurfacing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - day 1
Arm Type
Active Comparator
Arm Description
Group 1 will receive laser therapy to half of the scar the day of the excision.
Arm Title
Group 2 - day 14
Arm Type
Active Comparator
Arm Description
Group 2 will receive laser therapy at the time of suture removal or post-operative day 14.
Arm Title
Group 3 - week 9
Arm Type
Active Comparator
Arm Description
Group 3 will receive laser treatment to half the scar at the 9 week postop visit.
Intervention Type
Device
Intervention Name(s)
Laser Treatment
Other Intervention Name(s)
Lumenis UltraPulse Total FXTM fractionated CO2 laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
MMSS for Scar Halves Treated
Description
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
Secondary Outcome Measure Information:
Title
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity
Description
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
Title
Quartile Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hooman Khorasani, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Post Excision/Mohs Scar Laser Resurfacing
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