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This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis.
Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design.
The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDL (Pulsed Dye Laser) and Fractional Photothermolysis | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDL (Pulsed Dye Laser) | Device | For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score of Patient and Observer Scar Assessment Scale (POSAS) | The POSAS is a series of questions about the scar with a scale from 1 to 10 with 1 as "not at all" or "normal skin" and 10 as "very much so" or "very different". | Baseline and 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35081564 | Derived | Kang BY, Ibrahim SA, Weil A, Reynolds KA, Johnson T, Wilson S, Lee MH, Kim JYS, Dirr MA, Poon E, Alam M. Treatment of Surgical Scars With Combination Pulsed Dye and Fractional Nonablative Laser: A Randomized Controlled Trial. Ann Surg. 2022 Dec 1;276(6):975-980. doi: 10.1097/SLA.0000000000005377. Epub 2022 Jan 25. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Fractional Photothermolysis Laser | Device | For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis. |
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