Cicatrix, Dermabrasion, Coagulation, Laser
Conditions
Keywords
Cicatrix, Dermabrasion, Coagulation, Laser
Brief summary
Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.
Interventions
DEVICEFractionated laser
Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.
DEVICEDermabrasion
Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Post-surgical or post traumatic scar on face or scalp. * Age 18 or older * Able to read and comprehend English * Willing to follow treatment schedule and post treatment care requirements * Signed the informed consent form * Fitzpatrick skin type I-III
Exclusion criteria
* known photosensitivity * Taken any medications known to induce photosensitivity in previous three months * Taken Accutane within past 12 months * Pregnant or nursing * Currently on topical or oral antibiotics * Immunocompromised status * Skin type IV or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Day 0, Week1, Month 1 | Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Assessing Scar Improvement. | 3 months | Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement 1. : 1-25% improvement 2. : 26-50% improvement 3. : 51-75% improvement 4. : 76-100% improvement |
Countries
United States
Participant flow
Recruitment details
Adult patients aged 18 and older were recruited from a reconstructive surgical practice. Preference was given to patients who had undergone interpolated axial flaps (e.g., forehead flaps) because this allowed treatment of two different scars on a single patient.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Scars 12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Patients With Scars |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 54.6 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing
Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.
Time frame: Day 0, Week1, Month 1
Population: Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Edema Day 0 | 0 units on a scale | Standard Error 0 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Bleeding Week 1 | 0 units on a scale | Standard Error 0 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Eschar Day 0 | 0 units on a scale | Standard Error 0 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Eschar Week 1 | 0.08 units on a scale | Standard Error 0.29 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema Day 0 | 1.33 units on a scale | Standard Error 0.49 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema Month 1 | 0.38 units on a scale | Standard Error 0.52 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema Week 1 | 0.75 units on a scale | Standard Error 0.45 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Edema Month 1 | 0 units on a scale | Standard Error 0 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Bleeding Day 0 | 1.08 units on a scale | Standard Error 0.29 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Bleeding Month 1 | 0 units on a scale | Standard Error 0 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Edema Week 1 | 0.17 units on a scale | Standard Error 0.39 |
| Fractionated Laser | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Eschar Month 1 | 0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Edema Week 1 | 0.50 units on a scale | Standard Error 0.52 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema Day 0 | 3.00 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Edema Day 0 | 0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Bleeding Day 0 | 2.0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Eschar Day 0 | 0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema Week 1 | 1.50 units on a scale | Standard Error 0.52 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Eschar Month 1 | 0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Bleeding Week 1 | 0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Eschar Week 1 | 0.92 units on a scale | Standard Error 0.79 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema Month 1 | 1.25 units on a scale | Standard Error 1.04 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Edema Month 1 | 0 units on a scale | Standard Error 0 |
| Dermabrasion | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Bleeding Month 1 | 0 units on a scale | Standard Error 0 |
Secondary
Visual Analog Scale for Assessing Scar Improvement.
Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement 1. : 1-25% improvement 2. : 26-50% improvement 3. : 51-75% improvement 4. : 76-100% improvement
Time frame: 3 months
Population: With 12 pairs of scars gave a 95% probability to detect a treatment difference at a two sided 0.05 significance level if a significant difference between treatments is 1.5 units (based on a 0~-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fractionated Laser | Visual Analog Scale for Assessing Scar Improvement. | 1.53 units on a scale | Standard Deviation 0.59 |
| Dermabrasion | Visual Analog Scale for Assessing Scar Improvement. | 1.49 units on a scale | Standard Deviation 0.39 |
Comparison: efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group's scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categoriesp-value: 0.77Wilcoxon (Mann-Whitney)