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

Not Applicable

Terminated

Interventions: Device: pulsed dye laser
Device: combined PDL and Affirm Lasers
Device: Affirm Laser
Other: Placebo

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pulsed dye laser	pulsed dye laser	PDL Patient will be have scar treated with pulsed dye laser.
combined PDL and Affirm Lasers	combined PDL and Affirm Lasers	Patient will be have scar treated with combined Affirm + PDL
Affirm laser	Affirm Laser	Patient will be have scar treated with Affirm Laser
Placebo	Placebo	Patient will be have scar treated with Placebo

Primary Outcome Measures

Name	Time	Method
Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar	1 year	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.

Secondary Outcome Measures