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Effects of Pulsed-Dyed Laser on Scar Formation

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. Identifier: NCT00852280
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
John Kevin Bailey, Shriners Hospitals for Children

Brief Summary:
The purpose of this study is to identify changes in color, thickness, and stiffness, of scars from skin grafting after burns when treated with a pulsed-dyed laser.

Condition or disease Intervention/treatment Phase
Scars Device: Treatment of 1/2 of skin graft with pulsed-dye laser Not Applicable

Detailed Description:

Pulsed-dyed lasers have been used in the past to treat scars from minor surgery as well as burns. The laser has been used at different times, close to injury or late after injury. Success or failure of the laser has been judged by subjective observer scales.

In this study we will treat the seams of 1/2 of a skin graft with a pulsed-dyed laser, beginning about one month after surgery. We will use objective measures of color (redness on digital pictures), scar volume(via laser scanning), and elasticity(measured by BTC-2000) as well as subjective assessment by an independent observer and the patient.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pulsed-Dyed Laser on Scar Formation
Study Start Date : December 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Intervention Details:
  • Device: Treatment of 1/2 of skin graft with pulsed-dye laser
    Pulsed-dye laser will be applied to 1/2 of the seam of the skin graft, using a 10mm spot size, and sufficient pulse-width and fluency to induce purpura.

Primary Outcome Measures :
  1. Amount of redness of scar [ Time Frame: 4 to 12 months after skin grafting ]

Secondary Outcome Measures :
  1. Scar height [ Time Frame: 4-12 months after skin grafting ]
  2. Scar stiffness [ Time Frame: 4-12 months after skin grafting ]
  3. Patient's assessment of cosmetic outcome [ Time Frame: 4-12months after skin grafting ]
  4. Clinical improvement of appearance of scars assessed by subjective scale [ Time Frame: 4-12 months after skin grafting ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • > 9 years old
  • not pregnant
  • new skin graft to extremity
  • able to follow simple instructions

Exclusion Criteria:

  • age less than 9 years
  • pregnancy
  • any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions

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 identifier (NCT number): NCT00852280

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United States, Ohio
Shriners Hospitals for Children, Cincinnati
Cincinnati, Ohio, United States, 45229-3095
Sponsors and Collaborators
Shriners Hospitals for Children
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Principal Investigator: John K Bailey, MD Shriners Hosptials for Children
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Responsible Party: John Kevin Bailey, J. Kevin Bailey, MD Staff Surgeon, Shriners Hospitals for Children Identifier: NCT00852280    
Other Study ID Numbers: 08-6-24-1
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: July 2010
Keywords provided by John Kevin Bailey, Shriners Hospitals for Children:
late effect of burn
pulsed-dye laser
Additional relevant MeSH terms:
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Pathologic Processes