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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Abdominoplasty Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pulsed dye laser

PDL Patient will be have scar treated with pulsed dye laser.

Group Type ACTIVE_COMPARATOR

pulsed dye laser

Intervention Type DEVICE

patient will have scar treated with pulsed dye laser

Affirm laser

Patient will be have scar treated with Affirm Laser

Group Type ACTIVE_COMPARATOR

Affirm Laser

Intervention Type DEVICE

patient will have scar treated with Affirm laser

combined PDL and Affirm Lasers

Patient will be have scar treated with combined Affirm + PDL

Group Type ACTIVE_COMPARATOR

combined PDL and Affirm Lasers

Intervention Type DEVICE

patient will have scar treated with Affirm and pulsed dye lasers

Placebo

Patient will be have scar treated with Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

patient will receive no treatment

Interventions

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pulsed dye laser

patient will have scar treated with pulsed dye laser

Intervention Type DEVICE

Affirm Laser

patient will have scar treated with Affirm laser

Intervention Type DEVICE

combined PDL and Affirm Lasers

patient will have scar treated with Affirm and pulsed dye lasers

Intervention Type DEVICE

Placebo

patient will receive no treatment

Intervention Type OTHER

Other Intervention Names

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VBEAM non-ablative laser VBEAM, non-ablative laser

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes