Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

Conditions
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Abdominoplasty Scars

Intervention / Treatment
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* Device: pulsed dye laser
* Device: Affirm Laser
* Device: combined PDL and Affirm Lasers
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older No significant medical illness Surgical procedure that involves closure of the transverse abdominal incision performed in the department of dermatology and plastic surgery at the Cleveland Clinic main campus. Subjects with the willingness and ability to understand and provide informed consent Exclusion Criteria: Under 18 years of age Pregnancy or Lactation Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months Subjects with liver/kidney disease, diabetes mellitus, hypertension, connective tissue disease or who are immunocompromised Subjects with a known susceptibility to keloid formation or hypertrophic scarring Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness Subjects with obvious non-healing wound

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed dye laser<br>PDL Patient will be have scar treated with pulsed dye laser. | Device: pulsed dye laser<br>* patient will have scar treated with pulsed dye laser<br>* Other names: VBEAM;|
| Active Comparator: Affirm laser<br>Patient will be have scar treated with Affirm Laser | Device: Affirm Laser<br>* patient will have scar treated with Affirm laser<br>* Other names: non-ablative laser;|
| Active Comparator: combined PDL and Affirm Lasers<br>Patient will be have scar treated with combined Affirm + PDL | Device: combined PDL and Affirm Lasers<br>* patient will have scar treated with Affirm and pulsed dye lasers<br>* Other names: VBEAM, non-ablative laser;|
| Placebo Comparator: Placebo<br>Patient will be have scar treated with Placebo | Other: Placebo<br>* patient will receive no treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post, surgical