Effects of Pulsed-Dyed Laser on Scar Formation | NCT00852280

Studies
Effects of Pulsed-Dyed Laser on Scar Formation

NCT00852280

Sponsor

Shriners Hospitals for Children

Status

Completed

Last Update Posted

Jun 7, 2012Estimated

Enrollment

17Actual

Phase

Not Applicable

Conditions

Scars

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jan 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Feb 25, 2009

First Submission Date that Met QC Criteria

Feb 25, 2009

First Posted Date

Feb 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2012

Last Update Posted Date

Jun 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Kevin Bailey, J. Kevin Bailey, MD Staff Surgeon, Shriners Hospitals for ChildrenPrincipal Investigator

Lead Sponsor

Shriners Hospitals for ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment of 1/2 of skin graft with pulsed-dye laser	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Scar height		4-12 months after skin grafting
Scar stiffness		4-12 months after skin grafting
Patient's assessment of cosmetic outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John K Bailey, MD	Shriners Hosptials for Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shriners Hospitals for Children, Cincinnati		Cincinnati	Ohio	45229-3095	United States

Type	Date	Date Unknown
Release	Dec 7, 2012
Reset	Jan 14, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 7, 2012			Jan 14, 2013

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix
D002056	Burns

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054025	Lasers, Dye

Ancestor Terms

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided