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| Name | Class |
|---|---|
| United States Army Institute of Surgical Research | FED |
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A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulse Dye Laser | Experimental | Treatment with PDL alone. |
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| CO2 Laser | Experimental | Treatment with CO2 alone. |
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| Combination | Experimental | Treatment with both PDL and CO2 laser. |
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| No treatment | Active Comparator | No laser treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Pulse Dye Laser | Procedure | Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of laser treatments | Using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS) | 4-6 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of symptoms | To longitudinally compare the change in symptoms by treatment modality between treatment sessions by assessment with the Patient and Observer Scar Assessment Scale (POSAS) measured for each patient and two observers (to increase score reliability) at each follow-up visit. | 4-6 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney Chan, MD | Metis Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943226 | Derived | Cooper LE, Nuutila K, Kemp Bohan PM, Diaz V, Batchinsky M, Carlsson AH, Cancio LC, Chan RK. Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars. Ann Plast Surg. 2022 Aug 1;89(2):166-172. doi: 10.1097/SAP.0000000000003240. |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Treatment with CO2 Laser | Procedure | CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density. |
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| Treatment with combination of pulse dye laser and CO2 laser. | Procedure | Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density. |
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| Control | Other | One area will be randomized to receive no laser treatment. |
|