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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735254
Recruitment Status : Terminated (PI decision)
First Posted : August 14, 2008
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Abdominoplasty Scars Device: pulsed dye laser Device: Affirm Laser Device: combined PDL and Affirm Lasers Other: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars
Study Start Date : July 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pulsed dye laser
PDL Patient will be have scar treated with pulsed dye laser.
 Device: pulsed dye laser
patient will have scar treated with pulsed dye laser
Other Name: VBEAM
Active Comparator: Affirm laser
Patient will be have scar treated with Affirm Laser
 Device: Affirm Laser
patient will have scar treated with Affirm laser
Other Name: non-ablative laser
Active Comparator: combined PDL and Affirm Lasers
Patient will be have scar treated with combined Affirm + PDL
 Device: combined PDL and Affirm Lasers
patient will have scar treated with Affirm and pulsed dye lasers
Other Name: VBEAM, non-ablative laser
Placebo Comparator: Placebo
Patient will be have scar treated with Placebo
 Other: Placebo
patient will receive no treatment


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735254


Locations
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United States, Ohio
Cleveland Clinical Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Study Director: Rebecca Tung, MD The Cleveland Clinic
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00735254    
Other Study ID Numbers: 08-352
First Posted: August 14, 2008    Key Record Dates
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Cleveland Clinic:
post
surgical