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Effects of Pulsed-Dyed Laser on Scar Formation

This study has been completed.
Information provided by (Responsible Party):
John Kevin Bailey, Shriners Hospitals for Children Identifier:
First received: February 25, 2009
Last updated: June 6, 2012
Last verified: July 2010
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 Intervention
Device: Treatment of 1/2 of skin graft with pulsed-dye laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pulsed-Dyed Laser on Scar Formation

Resource links provided by NLM:

Further study details as provided by John Kevin Bailey, Shriners Hospitals for Children:

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

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

Enrollment: 17
Study Start Date: December 2008
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.
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.


Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00852280

United States, Ohio
Shriners Hospitals for Children, Cincinnati
Cincinnati, Ohio, United States, 45229-3095
Sponsors and Collaborators
Shriners Hospitals for Children
Principal Investigator: John K Bailey, MD Shriners Hosptials for Children
  More Information

Responsible Party: John Kevin Bailey, J. Kevin Bailey, MD Staff Surgeon, Shriners Hospitals for Children Identifier: NCT00852280     History of Changes
Other Study ID Numbers: 08-6-24-1
Study First Received: February 25, 2009
Last Updated: June 6, 2012

Keywords provided by John Kevin Bailey, Shriners Hospitals for Children:
late effect of burn
pulsed-dye laser processed this record on May 25, 2017