NCT00852280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 7, 2012

Status Verified

July 1, 2010

Enrollment Period

2.1 years

First QC Date

February 25, 2009

Last Update Submit

June 6, 2012

Conditions

Scars

Keywords

scarslate effect of burnburnpulsed-dye laser

Outcome Measures

Primary Outcomes (1)

  • Amount of redness of scar

    4 to 12 months after skin grafting

Secondary Outcomes (4)

  • Scar height

    4-12 months after skin grafting

  • Scar stiffness

    4-12 months after skin grafting

  • Patient's assessment of cosmetic outcome

    4-12months after skin grafting

  • Clinical improvement of appearance of scars assessed by subjective scale

    4-12 months after skin grafting

Interventions

Treatment of 1/2 of skin graft with pulsed-dye laserDEVICE

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.

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \> 9 years old
  • not pregnant
  • new skin graft to extremity
  • able to follow simple instructions

You may not qualify if:

  • age less than 9 years
  • pregnancy
  • any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children, Cincinnati

Cincinnati, Ohio, 45229-3095, United States

Location

MeSH Terms

Conditions

CicatrixBurns

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • John K Bailey, MD

    Shriners Hosptials for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J. Kevin Bailey, MD Staff Surgeon

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

June 7, 2012

Record last verified: 2010-07

Locations

US(1)