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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - day 1 | Active Comparator | Group 1 will receive laser therapy to half of the scar the day of the excision. |
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| Group 2 - day 14 | Active Comparator | Group 2 will receive laser therapy at the time of suture removal or post-operative day 14. |
|
| Group 3 - week 9 | Active Comparator | Group 3 will receive laser treatment to half the scar at the 9 week postop visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MMSS for Scar Halves Treated | modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes | Day 0 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hooman Khorasani, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Original protocol had 3 arms. Due to difficulty with enrollment, study did not perform a laser treatment at 9 weeks and the enrolled participants were all given the same intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Fitzpatrick Skin Phototype I or II | Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Fitzpatrick Skin Phototype I or II | Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MMSS for Scar Halves Treated | modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes | Posted | Mean | Full Range | score on a scale | Day 0 and Day 14 |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Fitzpatrick Skin Phototype I or II | Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| transient erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
Single-center study with wounds limited to limbs of skin phototype I-II subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hooman Khorasani | Icahn School of Medicine at Mount Sinai | 347-574-8500 | hooman.khorasani@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2019 | Sep 11, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2018 | Sep 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
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| 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. | 24 weeks post-op |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Scar length | Mean | Full Range | cm |
|
|
| Secondary | 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. | Posted | Mean | Full Range | units on a scale | Day 0 and Day 14 |
|
|
|
| Secondary | 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. | Data not collected | Posted | 24 weeks post-op |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 20 |
| 26 |
| swelling and crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D005355 |
| Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Lacunarity Day 14 |
|