Effects of Pulsed-Dyed Laser on Scar Formation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

John Kevin Bailey, Shriners Hospitals for Children

ClinicalTrials.gov Identifier:

NCT00852280

First received: February 25, 2009

Last updated: June 6, 2012

Last verified: July 2010

History of Changes

Purpose

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
Scars	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:

MedlinePlus related topics: Burns Scars

U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:

Amount of redness of scar [ Time Frame: 4 to 12 months after skin grafting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scar height [ Time Frame: 4-12 months after skin grafting ] [ Designated as safety issue: No ]
Scar stiffness [ Time Frame: 4-12 months after skin grafting ] [ Designated as safety issue: No ]
Patient's assessment of cosmetic outcome [ Time Frame: 4-12months after skin grafting ] [ Designated as safety issue: No ]
Clinical improvement of appearance of scars assessed by subjective scale [ Time Frame: 4-12 months after skin grafting ] [ Designated as safety issue: No ]

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:

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.

Eligibility

Ages Eligible for Study:	9 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852280

Locations

United States, Ohio
Shriners Hospitals for Children, Cincinnati
Cincinnati, Ohio, United States, 45229-3095

Sponsors and Collaborators

Shriners Hospitals for Children

Investigators

Principal Investigator:

John K Bailey, MD

Shriners Hosptials for Children

More Information

No publications provided

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

Keywords provided by Shriners Hospitals for Children:

scars
late effect of burn
burn
pulsed-dye laser

Additional relevant MeSH terms:

Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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