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| Name | Class |
|---|---|
| CynosureLutronic | INDUSTRY |
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Surgical standard for treating traumatic burn injury scarring is to wait one year following the initial assault prior to beginning treatment. This study investigates the use of fractional ablative CO2 laser when begun within 3 months of a traumatic burn injury and it's impact on scar formation compared to the control. We hypothesized that early intervention would substantially mitigate the formation of scar tissue and help restore more normal appearing skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional ablative CO2 laser | Device | Three treatments with a fractional ablative CO2 laser 8 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Manchester Scar Scale | The sum total of the Manchester Scar Scale to assess the change in scar characteristics. The scale includes the following categories: Color, matte vs shiny, contour, distortion, and texture. Scales for color, contour, distortion, and texture are rated on a 1-4 scale with 1 being most normal and 4 being most abnormal. Matte vs shiny is rated on a 1 to 2 scale with 1 being matte and 2 being shiny. Assessments completed by blinded evaluators. A decrease in score indicates improvement in scar characteristics. | From the day of the first treatment prior to intervention and at 6 months following the final treatment |
| Digital photography | Visual improvement as demonstrated in digital photography. Before and after photos identified by blinded evaluators | From the day of the first treatment prior to intervention and at 6 months following the final treatment |
| Changes in scar characteristics such as dermal and epidermal character as well as vascular structure and organization assessed through histology. | Some patients elected to do optional biopsies for deeper evaluation of changes in skin structure. Biopsies were taken prior to treatment and 6 months following treatment to assess dermal and epidermal character as well as the size and organization of vasculature. Evaluation was done qualitatively. | From the day of the first treatment prior to intervention and at 6 months following the final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Optical Coherence Tomography | Patients were scanned using OCT for noninvasive skin imaging of both control and treatment areas | From the day of the first treatment prior to intervention and at 6 months following the final treatment |
| Treatment Time |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31631361 | Derived | Waibel JS, Gianatasio C, Rudnick A. Randomized, Controlled Early Intervention of Dynamic Mode Fractional Ablative CO2 Laser on Acute Burn Injuries for Prevention of Pathological Scarring. Lasers Surg Med. 2020 Feb;52(2):117-124. doi: 10.1002/lsm.23170. Epub 2019 Oct 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 19, 2020 | |
| Reset | Mar 3, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 19, 2020 | Mar 3, 2020 |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D000081084 | Accidental Injuries |
| D002056 | Burns |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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Each subject possessed extensive burn wounds. Wounds on each subject were divided into treatment arms of intervention with fractional ablative CO2 laser and control.
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The treatment and control areas were randomized in advanced such that the investigator did not choose which sections to treat. Control areas were covered during the treatment so the investigator/provider could only see areas to be treated. Outcomes assessors evaluated photographs without knowledge of the identity of each area. The participant could not be masked due the experience of receiving treatment.
The total duration of each treatment was measured in minutes to assess treatment characteristics for large surface areas
| Treatment time was measured at each of the three treatments conducted on day 0, day 60, and day 120 |
| Severity of post treatment cutaneous responses as evaluated by the investigator | Cutaneous responses including purpura, edema, erythema, hyperpigmentation, hypopigmentation, blistering and scarring were assessed following each treatment. Areas were rated on a 1-4 scale where 1 = none, 2 = mild, 3 = moderate, and 4 = severe. | Post treatment response was assessed immediately post treatment at each of the three treatments conducted on day 0, day 60, and day 120 |