Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG (Er:YAG)
Primary Purpose
Post-Surgical Scars
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Er:YAG laser, traditional and fractional settings
Sponsored by
About this trial
This is an interventional treatment trial for Post-Surgical Scars focused on measuring scar, ICD-10 CM:L90.5
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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.
Outcomes
Primary Outcome Measures
Patient Observer Scar Assessment Scale (POSAS)
It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.
Secondary Outcome Measures
Patient Preference
The number of patients who preferred the fractionated laser
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02397564
Brief Title
Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
Acronym
Er:YAG
Official Title
Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Surgical Scars
Keywords
scar, ICD-10 CM:L90.5
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Er:YAG laser, traditional and fractional settings
Intervention Description
Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting
Primary Outcome Measure Information:
Title
Patient Observer Scar Assessment Scale (POSAS)
Description
It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Patient Preference
Description
The number of patients who preferred the fractionated laser
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S Brown, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
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