Post-Surgical Scars
Conditions
Keywords
scar, ICD-10 CM:L90.5
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.
Interventions
DEVICEEr:YAG laser, traditional and fractional settings
Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Observer Scar Assessment Scale (POSAS) | 5 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference | 5 months | The number of patients who preferred the fractionated laser |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group 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.
Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 46 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Patient Observer Scar Assessment Scale (POSAS) | Physician Fully Ablative Laser | 17.69 units on a scale | Standard Error 2.03 |
| Treatment Group | Patient Observer Scar Assessment Scale (POSAS) | Physician Fractionated Laser | 11.2 units on a scale | Standard Error 2.03 |
| Treatment Group | Patient Observer Scar Assessment Scale (POSAS) | Patients Fully Ablative Laser | 15.2 units on a scale | Standard Error 1.58 |
| Treatment Group | Patient Observer Scar Assessment Scale (POSAS) | Patients Fractionated Laser | 11.4 units on a scale | Standard Error 1.58 |
p-value: 0.019Wilcoxon (Mann-Whitney)
Secondary
Patient Preference
The number of patients who preferred the fractionated laser
Time frame: 5 months
Population: Those who expressed a preference.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Patient Preference | 15 Participants |