Effects of Pulsed-Dyed Laser on Scar Formation

Scars Clinical Trial

Official title:

Effects of Pulsed-Dyed Laser on Scar Formation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852280
• Other study ID #: 08-6-24-1
• Status: Completed
• Phase: N/A
• First received: February 25, 2009
• Last updated: June 6, 2012
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2010
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scars

Intervention

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.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children, Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of redness of scar		4 to 12 months after skin grafting
Secondary	Scar height		4-12 months after skin grafting
Secondary	Scar stiffness		4-12 months after skin grafting
Secondary	Patient's assessment of cosmetic outcome		4-12months after skin grafting
Secondary	Clinical improvement of appearance of scars assessed by subjective scale		4-12 months after skin grafting