Post-Surgical Scars Clinical Trial
Official title:
Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3 months. Then follow up for the next 2 months.
Background: Scars are a common complaint of patients at presentation to a dermatology
office. To optimize cosmetic results, the investigators propose to compare erbium-doped
yttrium aluminium garnet (Er:YAG) laser therapy on two different settings: traditional
ablative versus fractional ablative. A side to side comparison of split scars will be done
to evaluate the two settings. Fractionated photothermolysis (fractional setting) has
improved the field of laser surgery by allowing the surgery to target microscopic treatment
zones (MTZ). MTZ's allow for cylinders of damage created by laser surgery to be surrounded
by normal, unaffected skin. This acts as a reservoir for healing and allows for the
microwounds created by laser treatment to heal quickly and with minimal discomfort.
Objective: To compare efficacy and cosmetic appearance of scars treated with Er:YAG ablative
laser on traditional ablative resurfacing setting versus fractional ablative resurfacing
setting.
Methods: Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar
will be treated with the Er:YAG laser on the traditional ablative setting and the other half
of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients
will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after
the treatment. Pictures of the scar will be taken at a 45 degree and 90 degree angle at
baseline, before each treatment, after each treatment, and at all follow up appointments.
The patients will be blinded as to which side is treated with which laser setting. At the
end of the trial, they will be offered the chance to have the side they felt had less
improvement treated with the laser device that had been used on the contralateral side of
the scar.
Results: A panel of three blinded dermatologists will evaluate the scar on a
well-established five point grading scale for erythema, height and texture, and overall
cosmetic outcome. The mean, standard deviation, and kappa values will be calculated.
Patients will be asked the same scar evaluation questions as the panel as well as their
overall satisfaction, how much pain was associated with the procedure, which laser they
preferred, and would they recommend treatment to a friend or family member.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00991367 -
CICATRIX in the Treatment of Recent Post-surgical Scars
|
Phase 3 |