NCT04769089.
Study name | Effects of pulsed‐dye and CO2 laser in treatment of hypertrophic burn scars |
Methods | Randomised, double‐blinded, controlled trial |
Participants | Participants between 18 and 65 years old with at least 4 areas of burn scar located on the trunk or extremities measuring 3 cm x 3 cm and not previously treated with laser, with a minimum of 1 month after burn closure |
Interventions | Intervention 1: Pulse Dye Laser: Pulse Dye laser treatment will be applied to 1 randomised area with the 10 mm hand piece, duration of 0.45 ms, and fluence of 5.25 J/s. Intervention 2: CO2 Laser: CO2 laser treatment will be applied to 1 randomised area with the deep Fx hand piece, 300 Hz, 15 mJ, 15% density. Intervention 3: combination: Pulse Dye laser and CO2 treatment will be applied to 1 randomised area. Pulse Dye will be applied with the 10 mm hand piece, duration of 0.45 ms, and fluence of 5.25 J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300 Hz, 15 mJ, 15% density. Intervention 4: mo treatment: 1 area will be randomised to receive no laser treatment. |
Outcomes | Primary outcome: effectiveness of laser treatments: 4 to 6 weeks post treatment ‐ using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS). Secondary outcome: improvement of symptoms: 4 to 6 weeks post treatment ‐ to longitudinally compare the change in symptoms by treatment modality between treatment sessions by assessment with the Patient and Observer Scar Assessment Scale (POSAS) measured for each participant and 2 observers (to increase score reliability) at each follow‐up visit. |
Starting date | Not reported |
Contact information | Not provided |
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