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Completed

NCT Number: NCT00852280

Effects of Pulsed-Dyed Laser on Scar Formation

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.

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Key information

Conditions

Scars Burns Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospitals for Children, Cincinnati

Cincinnati, Ohio, 45229-3095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of 1/2 of skin graft with pulsed-dye laser

Device

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 outcomes

  1. Amount of redness of scar

    Time frame: 4 to 12 months after skin grafting

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2009
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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