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Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.
Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical scar - part 1 | Experimental | Surgical scar - part 1 |
|
| Surgical scar - part 2 | Placebo Comparator | Surgical scar - part 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed dye laser treatment | Procedure | Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician global assessment for the treated and control region (PhGA) | Before start of the study, 1 and 6 months after treatment | |
| Patient global assessment for the treated and control region (PGA) | Before start of the study, 1 and 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of scar color by colorimetry | Before start of the study, 1 and 6 months after treatment. | |
| Assessment of scar tickness by ultrasound measurements | Before start of the study, 1 and 6 months after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelien Verhaeghe, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| website of the University Hospital Ghent | View source |
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| Control | Procedure | Part 2 of the surgical scar will serve as a within patient control. |
|
| Assessment of viscoelasticity by Cutometer measurements | Before start of the study, 1 and 6 months after treatment. |
| Clinical scar assessment by the Vancouver Scar scale and POSAS scale. | Before the start of the PDL treatment, and 1 and 6 months after the last treatment. |