Treatment of 1/2 of skin graft with pulsed-dye laser in Scars - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Scars

Intervention / Treatment

Device: Treatment of 1/2 of skin graft with pulsed-dye 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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of redness of scar Time Frame: 4 to 12 months after skin grafting	4 to 12 months after skin grafting

Secondary Outcome Measures

Outcome Measure	Time Frame
Scar height Time Frame: 4-12 months after skin grafting	4-12 months after skin grafting
Scar stiffness Time Frame: 4-12 months after skin grafting	4-12 months after skin grafting
Patient's assessment of cosmetic outcome Time Frame: 4-12months after skin grafting	4-12months after skin grafting
Clinical improvement of appearance of scars assessed by subjective scale Time Frame: 4-12 months after skin grafting	4-12 months after skin grafting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Investigators

Principal Investigator: John K Bailey, MD, Shriners Hosptials for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria