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Difficulties in enrollment lead to withdrawing the study without enrollment.
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Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.
During our study, patients with painful and/or itchy burn scars will undergo standard treatment with fractional CO2 laser. In addition to the standard of care treatment, participants will undergo skin biopsies and be asked to complete Patient Reported Outcome Measure questionnaires related to their HTBS. Burn scars will also undergo standard and 3 dimensional photography at the different stages of treatment. Biopsy samples will undergo various staining techniques to establish the changes in tissue that occur with the laser treatment. This information will also be correlated with the symptomatic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luminis ultrapulse fractional ablative carbon dioxide laser | Device | This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological change in nerve density | The investigators will stain the collected skin with markers specific to nerves to in order to count the number of nerves per biopsy area. | 7 months |
| Histological change in nerve morphology | The investigators will stain the collected skin with markers specific to nerves to in order to compare the size and shape of cutaneous nerves before and after treatment. This will be based on subjective evaluation and not a predetermined scale. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Improvement Assessment | Patient Reported Outcome Measures will be collected via the Patient and Observer Scar Assessment Scale (POSAS). This is a validated questionnaire that includes 5 physician-completed parameters and 6 patient-reported measures. Each parameter is rated from 1-10 with a score of 1 representing "skin that appears close to normal" and 10 representing the "worst scare imaginable". Overall, the final score will range from 11( best outcome) to 110 (worst outcome). Physician parameters relate to the scar appearance such as color and thickness of the scar; while the patient-reported parameters also include symptomatic factors, such as degree of pain associated with the scar |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Friedstat, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D010146 | Pain |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 7 months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |