Burn ScarsLaserTherapyNCT01653691
Laser Therapy for Treating Hypertrophic Burn Scars in Children
A study testing Pulse-Dye Laser in people with Burn Scars, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy on children's burned scars has not been measured. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Burn Scars
- What is being tested?
- Pulse-Dye Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2015
- 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 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects 9 years and older to 21 years of age or younger with a second degree burn with erythema and the potential for hypertrophic scarring to the thigh and or trunk.
- subject is clinically stable within 3 months of the burn injury.
- burn size of at least 15cm2 and able to be divided into equivalent halves (divided along line of tension). Equivalent orientation distance from mobil joint with regard to history,physical findings, proximity to tension producing forces and orientation.
- subjects in acute phase of burn injury generally less than one year from the time of the burn injury at 2-3 months post burn when deemed appropriate for pressure therapy, and have been evaluated as an appropriate candidate by a surgeon involved in this study for inclusion.
- subjects can be included up to one year post burn if referred from another treatment facility.
- no skin conditions that could potentially have an adverse effect on wound healing
- all race/ethnic groups
- children/guardians or significant others ability to speak English or Spanish and respond to study questionnaires.
Who cannot join
- subjects less than 9 years old as this age group is more fragile.
- subjects with no second degree burn to thigh and or trunk
- subjects with chemical burns
- subjects at low risk for hypertrophic scaring (wounds that demonstrate fading erythema at 9-12 weeks and wounds that are healed at less than 3 weeks are at low risk for hypertrophic scaring). Vancouver scar scale pigmentation rating of 0 or 1, vascularity rating of 0 or 1.
- TBSA greater than 50% as massive burns will confound results.
- potential life threatening injuries which would confound the effects of laser treatment and complicate sequential administration of therapy (e.g. shock,sepsis,inhalation therapies, brain injury).
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- subjects with other inclusion criteria not met and evaluation by surgeon negative for inclusion in study.
- children/guardians or significant others inability to speak English or Spanish and respond to questionnaires.
- SUBJECTS WITH DOCUMENTED HYPERSENSITIVITY/ALLERGY TO AQUAPHOR,LIDOCAINE OR ANY OF THEIR COMPONENTS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Cincinnati, Ohio, 45229-3095
Kevin Bailey, MD, 513-872-6000, kbailey@shrinenet.org
Richard Kagan, MD, 513-872-6000, rkagan@shrinenet.org
About this study
Official title: Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children
Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy on children's burned scars has not been measured.
Read the detailed description
In this study we hope to answer an important question in pediatric burn care: what are the techniques whereby tunable-dye laser neo-vessel ablation is optimally employed to ameliorate hypertrophic scars resulting from burn injuries in children? Hypertrophic scarring is considered an adverse wound healing event that results in abnormal scar formation. This scarring process is associated with pruritis and discomfort and can interfere with function and aesthetics. Topical creams, massage, stretching and pressure are used as standard treatments of burn scar formation. With the child serving as their own control, we want to objectively measure the impact of PDL on burn scars in children. Variables of timing of application, duration and number of sessions will all be collected.
- Conditions
- Burn Scars
- Being tested
- Pulse-Dye Laser, Sham
- Keywords
- Pediatric, Burns, Scars, Pulse Dye laser
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse-Dye LaserProcedure or surgery
Also called Candela V-Beam tunable dye laser.
Laser therapy will be applied to either one half or both halves of the subject's burn scar. Laser will be re-applied every 4-6 weeks for a total of 3 administrations.
ShamProcedure or surgery
Also called No treatment
No treatment to one side of subject's scar.
| Study group | Role | What they receive |
|---|---|---|
| Pulse Dye Laser, burn scars | Active comparator | A scar will be located on the study subject's torso or thigh and divided in half. Some subjects will receive laser to both sides of their scar, while others will not receive any intervention to one side and laser to the other side. Each side will be evaluated during outpatient visits. 12 months after treatment is completed, 2 burn experts will rate each side of the scar without knowing its treatment. Receives: Procedure: Pulse-Dye Laser |
| No treatment to half of scar | Sham comparator | A scar on the child's torso or thigh will be divided in half. One side will receive laser treatment and the other half will receive laser or sham treatment. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matching Assessment of Scars and Photographs
This scar assessment tool uses a set of reference photographs, a numeric scale, and location technique to measure change over time of a burn scar. This tool will assist us in determining the comparative merits of laser treatments. It is portable and inexpensive.
Measured: 12 months after the first laser procedure is completed
Secondary outcomes (1)
Burn Outcomes Questionnaire
The ABA/SHC Burn Outcomes Questionnaires are burn and age specific. Questions include those about itch, appearance and function; all elements of daily life that may be compromised by hypertrophic scars.
Measured: Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Principal investigator, Mattias Donelan, Massachusetts General Hospital
- Investigators
- Matthias Donelan, MD, Principal investigator, Shriners Hospitals for Children-Boston MA USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653691
- Sponsor's protocol ID
- 2010-P-002148
- Acronym
- LaserTherapy
- Status last verified
- Jul 2012
- First submitted
- 27 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children
- ClinicalTrials.gov ID
- NCT01653691
- Acronym / sponsor ID
- LaserTherapy / 2010-P-002148
- Conditions
- Burn Scars
- Keywords
- Pediatric, Burns, Scars, Pulse Dye laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- May 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 31 Jul 2012 (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.
Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy on children's burned scars has not been measured.
Detailed description
In this study we hope to answer an important question in pediatric burn care: what are the techniques whereby tunable-dye laser neo-vessel ablation is optimally employed to ameliorate hypertrophic scars resulting from burn injuries in children? Hypertrophic scarring is considered an adverse wound healing event that results in abnormal scar formation. This scarring process is associated with pruritis and discomfort and can interfere with function and aesthetics. Topical creams, massage, stretching and pressure are used as standard treatments of burn scar formation. With the child serving as their own control, we want to objectively measure the impact of PDL on burn scars in children. Variables of timing of application, duration and number of sessions will all be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulse Dye Laser, burn scars | Active comparator | Procedure: Pulse-Dye LaserA scar will be located on the study subject's torso or thigh and divided in half. Some subjects will receive laser to both sides of their scar, while others will not receive any intervention to one side and laser to the other side. Each side will be evaluated during outpatient visits. 12 months after treatment is completed, 2 burn experts will rate each side of the scar without knowing its treatment. |
| No treatment to half of scar | Sham comparator | Procedure: ShamA scar on the child's torso or thigh will be divided in half. One side will receive laser treatment and the other half will receive laser or sham treatment. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- subjects 9 years and older to 21 years of age or younger with a second degree burn with erythema and the potential for hypertrophic scarring to the thigh and or trunk.
- subject is clinically stable within 3 months of the burn injury.
- burn size of at least 15cm2 and able to be divided into equivalent halves (divided along line of tension). Equivalent orientation distance from mobil joint with regard to history,physical findings, proximity to tension producing forces and orientation.
- subjects in acute phase of burn injury generally less than one year from the time of the burn injury at 2-3 months post burn when deemed appropriate for pressure therapy, and have been evaluated as an appropriate candidate by a surgeon involved in this study for inclusion.
- subjects can be included up to one year post burn if referred from another treatment facility.
Key exclusion criteria (9 listed)
- subjects less than 9 years old as this age group is more fragile.
- subjects with no second degree burn to thigh and or trunk
- subjects with chemical burns
- subjects at low risk for hypertrophic scaring (wounds that demonstrate fading erythema at 9-12 weeks and wounds that are healed at less than 3 weeks are at low risk for hypertrophic scaring). Vancouver scar scale pigmentation rating of 0 or 1, vascularity rating of 0 or 1.
- TBSA greater than 50% as massive burns will confound results.
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 |
|---|---|---|
| Pulse-Dye LaserAlso: Candela V-Beam tunable dye laser.Laser therapy will be applied to either one half or both halves of the subject's burn scar. Laser will be re-applied every 4-6 weeks for a total of 3 administrations. | Procedure or surgery | Pulse Dye Laser, burn scars |
| ShamAlso: No treatmentNo treatment to one side of subject's scar. | Procedure or surgery | No treatment to half of scar |
Primary outcome
Matching Assessment of Scars and Photographs
Time frame: 12 months after the first laser procedure is completed
This scar assessment tool uses a set of reference photographs, a numeric scale, and location technique to measure change over time of a burn scar. This tool will assist us in determining the comparative merits of laser treatments. It is portable and inexpensive.
1 secondary outcome
Burn Outcomes Questionnaire
Time frame: Baseline completion after enrollment and again at 1st,2nd, 3rd, 4th,5th and 6th outpatient visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Matthias Donelan, MD principal investigator
Shriners Hospitals for Children-Boston MA USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse-Dye Laser in people with Burn Scars, run by Massachusetts General Hospital 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Jul 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha Lydon, RN,BS (617-371-4808, mlydon@shrinenet.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matching Assessment of Scars and Photographs (time frame: 12 months after the first laser procedure is completed). 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 31 Jul 2012.