Effects of Pulsed-Dyed Laser on Scar Formation

NCT ID: NCT00852280

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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John Kevin Bailey

J. Kevin Bailey, MD Staff Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John K Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hosptials for Children

Locations

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Shriners Hospitals for Children, Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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08-6-24-1

Identifier Type: -

Identifier Source: org_study_id

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