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Effects of Pulsed-Dyed Laser on Scar Formation

Primary Purpose

Scars

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment of 1/2 of skin graft with pulsed-dye laser
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring scars, late effect of burn, burn, pulsed-dye laser

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shriners Hospitals for Children, Cincinnati

Outcomes

Primary Outcome Measures

Amount of redness of scar

Secondary Outcome Measures

Scar height
Scar stiffness
Patient's assessment of cosmetic outcome
Clinical improvement of appearance of scars assessed by subjective scale

Full Information

First Posted
February 25, 2009
Last Updated
June 6, 2012
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT00852280
Brief Title
Effects of Pulsed-Dyed Laser on Scar Formation
Official Title
Effects of Pulsed-Dyed Laser on Scar Formation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars
Keywords
scars, late effect of burn, burn, pulsed-dye laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Treatment of 1/2 of skin graft with pulsed-dye laser
Intervention Description
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 Measure Information:
Title
Amount of redness of scar
Time Frame
4 to 12 months after skin grafting
Secondary Outcome Measure Information:
Title
Scar height
Time Frame
4-12 months after skin grafting
Title
Scar stiffness
Time Frame
4-12 months after skin grafting
Title
Patient's assessment of cosmetic outcome
Time Frame
4-12months after skin grafting
Title
Clinical improvement of appearance of scars assessed by subjective scale
Time Frame
4-12 months after skin grafting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Bailey, MD
Organizational Affiliation
Shriners Hosptials for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children, Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3095
Country
United States

12. IPD Sharing Statement

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Effects of Pulsed-Dyed Laser on Scar Formation

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