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PI decision
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The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.
In summary, we will perform a total of three laser treatments. A personal interview, clinical examination, and a photograph will be taken at each visit. At the end of the three treatments, a final personal interview, clinical evaluation and photograph will be taken to document the effects of the laser treatments. At the end of the study, the patient will have the option to receive two additional laser treatments four weeks apart, also at no cost, to the entire scar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed dye laser | Active Comparator | PDL Patient will be have scar treated with pulsed dye laser. |
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| Affirm laser | Active Comparator | Patient will be have scar treated with Affirm Laser |
|
| combined PDL and Affirm Lasers | Active Comparator | Patient will be have scar treated with combined Affirm + PDL |
|
| Placebo | Placebo Comparator | Patient will be have scar treated with Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed dye laser | Device | patient will have scar treated with pulsed dye laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar | The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Tung, MD | The Cleveland Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinical Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulsed Dye Laser | PDL Patient will be have scar treated with pulsed dye laser. pulsed dye laser: patient will have scar treated with pulsed dye laser |
| FG001 | Affirm Laser | Patient will be have scar treated with Affirm Laser Affirm Laser: patient will have scar treated with Affirm laser |
| FG002 | Combined PDL and Affirm Lasers | Patient will be have scar treated with combined Affirm + PDL combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers |
| FG003 | Placebo | Patient will be have scar treated with Placebo Placebo: patient will receive no treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
PI left institution, no data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulsed Dye Laser | PDL Patient will be have scar treated with pulsed dye laser. pulsed dye laser: patient will have scar treated with pulsed dye laser |
| BG001 | Affirm Laser | Patient will be have scar treated with Affirm Laser Affirm Laser: patient will have scar treated with Affirm laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | PI left institution, no data available. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar | The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision. | study was not conducted per protocol, data was not collected, study terminated. Reported to IRB and closed study. | Posted | 1 year |
|
protocol was not followed and data was not collected. reported to IRB, closed study. PI left institution
protocol was not followed and data was not collected. reported to IRB, closed study. PI left institution
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulsed Dye Laser | PDL Patient will be have scar treated with pulsed dye laser. pulsed dye laser: patient will have scar treated with pulsed dye laser |
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protocol was not followed and data was not collected. reported to IRB, closed study. PI left institution
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Galiczynski, MD | Arizona Dermatology and Cosmetic | (602) 277-1449 | egaliczynski@arizonaderm.com |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Affirm Laser | Device | patient will have scar treated with Affirm laser |
|
|
| combined PDL and Affirm Lasers | Device | patient will have scar treated with Affirm and pulsed dye lasers |
|
|
| Placebo | Other | patient will receive no treatment |
|
| BG002 | Combined PDL and Affirm Lasers | Patient will be have scar treated with combined Affirm + PDL combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers |
| BG003 | Placebo | Patient will be have scar treated with Placebo Placebo: patient will receive no treatment |
| BG004 | Total | Total of all reporting groups |
PI left institution, no data available.
|
| Sex/Gender, Customized | PI left institution, no data available. | PI left institution, no data available. |
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| OG002 | Combined PDL and Affirm Lasers | Patient will be have scar treated with combined Affirm + PDL combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers |
| OG003 | Placebo | Patient will be have scar treated with Placebo Placebo: patient will receive no treatment |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Affirm Laser | Patient will be have scar treated with Affirm Laser Affirm Laser: patient will have scar treated with Affirm laser | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Combined PDL and Affirm Lasers | Patient will be have scar treated with combined Affirm + PDL combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Placebo | Patient will be have scar treated with Placebo Placebo: patient will receive no treatment | 0 | 0 | 0 | 0 | 0 | 0 |
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