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Due to staff shortages we are closing the study.
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This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2) laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.
The investigator will compare usual care (MED), which will be offered to all patients, to two types of laser treatment (PDL and CO2), which the investigators hypothesize to be beneficial. The timing and sequence of therapy will be randomized, but all patients will receive some form of laser treatment. If the investigators simply stopped at the end of Aim 1, the investigators would complete a traditional randomized control trial (RCT), with some patients potentially receiving laser treatment. However, the investigators are interested in determining whether the sequence of laser treatments is beneficial; therefore, the investigators will be employing a sequential multiple assignment randomized trial (SMART) design. Because of the nature of the study and SMART design, the investigators will offer all patients some form of laser therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2-CO2-Med | Active Comparator | Participants will receive two blocks of CO2 laser treatment, followed by one block of usual care. |
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| Med-CO2-CO2 | Active Comparator | Participants will receive one block of usual care, followed by two blocks of CO2 laser therapy. |
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| CO2-Med-CO2 | Active Comparator | Participants will receive one block of CO2 laser therapy, one block of usual care, and finally one more block of CO2 laser therapy. |
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| PDL-PDL-MED | Active Comparator | Participants will receive two blocks of PDL laser therapy, followed by one block of usual care. |
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| Med-PDL-PDL | Active Comparator | Participants will receive one block of usual care, followed by two blocks of PDL laser therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 laser treatment | Procedure | Surgical treatment using fractionated ablative carbon dioxide laser (CO2) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Hypotrophic scar score on the Vancouver Scar Scale (VSS) from baseline to three month visit | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term hypotrophic scar score on VSS | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Hultman, MD | UNC-Chapel Hill | Principal Investigator |
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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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| PDL-Med-PDL | Active Comparator | Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy. |
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| PDL-CO2-Med | Active Comparator | Participants will receive one block of PDL laser therapy, followed by one block of CO2 laser therapy, followed by one block of usual care. |
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| CO2-PDL-Med | Active Comparator | Participants will receive one block of CO2 laser therapy, followed by one block of PDL laser therapy, followed by one block of usual care. |
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| Med-PDL-CO2 | Active Comparator | Participants will receive one block of usual care, followed by one block of PDL laser therapy, followed by one block of CO2 laser therapy. |
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| Med-CO2-PDL | Active Comparator | Participants will receive one block of usual care, followed by one block of CO2 laser therapy, followed by one block of PDL laser therapy. |
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| PDL-Med-CO2 | Active Comparator | Participants will receive one block of PDL laser therapy, followed by one block of usual care, followed by one block of CO2 laser therapy. |
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| CO2-Med-PDL | Active Comparator | Participants will receive one block of CO2 laser therapy, followed by one block of usual care, followed by one block of PDL laser therapy. |
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| PDL laser treatment | Procedure | Surgical treatment using flashlamp-excited pulsed dye laser (PDL) |
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| Usual care | Other | Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting) |
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