Clinical trial NCT02397564: Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
Official title: Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Surgical Scars
Keywords: scar
ICD-10 CM:L90.5
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* over 8 weeks s/p scar
* linear closure
* visibly symmetric scar
* over 18 years old

Exclusion Criteria:

* concomitant treatment of involved skin
* propensity for keloid scarring
* use of oral retinoids for the past 1 year
* pregnancy
* immunosuppression
* prior laser to the area

Primary outcomes:
measure: Patient Observer Scar Assessment Scale (POSAS)
timeFrame: 5 months
Secondary outcomes:
measure: Patient Preference
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Louisville
name: Timothy S Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: