ScarsNCT00852280
Effects of Pulsed-Dyed Laser on Scar Formation
A study testing Treatment of 1/2 of skin graft with pulsed-dye laser in people with Scars, run by Shriners Hospitals for Children at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Scars
- What is being tested?
- Treatment of 1/2 of skin graft with pulsed-dye laser
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 9 years old
- not pregnant
- new skin graft to extremity
- able to follow simple instructions
Who cannot join
- age less than 9 years
- pregnancy
- any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children, Cincinnati
Cincinnati, Ohio, 45229-3095
About this study
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.
Read the 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.
- Conditions
- Scars
- Being tested
- Treatment of 1/2 of skin graft with pulsed-dye laser
- Keywords
- scars, late effect of burn, burn, pulsed-dye laser
- Medical subject headings
- Cicatrix, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of redness of scar
Measured: 4 to 12 months after skin grafting
Secondary outcomes (4)
Scar height
Measured: 4-12 months after skin grafting
Scar stiffness
Measured: 4-12 months after skin grafting
Patient's assessment of cosmetic outcome
Measured: 4-12months after skin grafting
Clinical improvement of appearance of scars assessed by subjective scale
Measured: 4-12 months after skin grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kevin Bailey, Shriners Hospitals for Children
- Investigators
- John K Bailey, MD, Principal investigator, Shriners Hosptials for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852280
- Sponsor's protocol ID
- 08-6-24-1
- Status last verified
- Jul 2010
- First submitted
- 25 Feb 2009
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulsed-Dyed Laser on Scar Formation
- ClinicalTrials.gov ID
- NCT00852280
- Acronym / sponsor ID
- 08-6-24-1
- Conditions
- Scars
- Keywords
- scars, late effect of burn, burn, pulsed-dye laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- > 9 years old
- not pregnant
- new skin graft to extremity
- able to follow simple instructions
Key exclusion criteria (3 listed)
- age less than 9 years
- pregnancy
- any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of 1/2 of skin graft with pulsed-dye laserPulsed-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. | Device | – |
Primary outcome
Amount of redness of scar
Time frame: 4 to 12 months after skin grafting
4 secondary outcomes
Scar height
Time frame: 4-12 months after skin grafting
Scar stiffness
Time frame: 4-12 months after skin grafting
Patient's assessment of cosmetic outcome
Time frame: 4-12months after skin grafting
Clinical improvement of appearance of scars assessed by subjective scale
Time frame: 4-12 months after skin grafting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John K Bailey, MD principal investigator
Shriners Hosptials for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of 1/2 of skin graft with pulsed-dye laser in people with Scars, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of redness of scar (time frame: 4 to 12 months after skin grafting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.