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BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars.
OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment.
HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and functional appearance.
METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | One area assessed as a control area, compared to the laser-treated area |
|
| Non-ablative Laser treatment | Active Comparator | 3 Non-ablative fractional laser treatments of one area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-ablative fractional laser | Radiation | 3 treatments with 4-6 weeks interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in overall Scar-appearance | Primary endpoint is change in overall scar-appearance assessed by a slightly modified Patient and Observer Scar Assessment Scale (evaluation of study area omitted since this is fixed as part of study procedure). Scale: 1= normal skin; 10= worst imaginable scar. | 1,3 and 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| specific clinical and histological scar appearance | Additional assessments include:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete Hædersdal, MD,PhD,DmSc | Bispebjerg Hospital, University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital, University of Copenhagen | Copenhagen NV | Copenhagen | DK-2400 | Denmark |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| control | Other | observation, comparison to laser-treated area |
|
|
| 1, 3, and 6 months follow-up |