Burn ScarsNCT02115646
Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
A study testing fractionated carbon dioxide laser in people with Burn Scars, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Burn Scars
- What is being tested?
- fractionated carbon dioxide laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy males and females between 5 and 70 years of age with hypertrophic and/or contracted burn scars with or without involvement of mobile joints. The burn scars must have occurred at least 1 year prior to the date of enrollment.
- Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months, and the scars must be deemed stable for a period of 3 months before initiation of treatment.
- Fitzpatrick skin types I-VI
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements
- Able to understand provide written informed consent
- Women of child-bearing age are required to be using a reliable method of birth control at least three months prior to study enrollment and throughout the course of the study.
Who cannot join
- Pregnant, intending to become pregnant during the course of the study, less than three months postpartum or less than six weeks after completion of breastfeeding.
- Active tanning, including the use of tanning booths, during the course of the study
- Showing symptoms of hormonal disorders (i.e.: uncontrolled thyroid disease or Polycystic Ovary Syndrome), as per the Investigator's discretion
- Abnormal photosensitivity due to metabolic disorder or due to use of external agents, (drugs, herbs, etc.) within 2 weeks of initial treatment or during the course of the study, except for use of aminolevulinic acid(Levulan®) which requires a washout period of three months
- Prior use of retinoids in treated areas within three months of initial treatment or during the course of the study
- Use of oral isotretinoin (Accutane®) within nine months of initial treatment or during the course of the study. Note: skin must retain its normal degree of moisture prior to treatment
Show all 19Show fewer
- Prior skin treatment with laser or other devices in the treated area within three months of initial treatment or during the course of the study
- Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists
- History of collagen vascular disease
- Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any severity
- Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment
- Multiple dysplastic nevi in area to be treated
- Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion)
- History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications
- Having any form of active cancer at the time of enrollment and during the course of the study
- Significant concurrent illness, such as uncontrolled diabetes, (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process)
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study
- If it is determined that the contracture is due to a deeper process involving the muscles, ligaments or bones.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital- Boston
Boston, Massachusetts, 02114
About this study
The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment.
Read the detailed description
The primary goal of the study will analyze whether the fractionated carbon dioxide laser can improve other subjective and objective qualities of hypertrophic and/or contracted burn scars with or without involvement of nearby mobile joints.
The investigators hypothesize that fractionated carbon dioxide laser therapy will increase range of motion and improve tissue compliance in all scars overlying a mobile joint that has been limited due to burn scar contracture. In addition, the investigators will evaluate the effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or contracted burn scars.
- Conditions
- Burn Scars
- Being tested
- fractionated carbon dioxide laser
- Keywords
- burn, scar
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractionated carbon dioxide laserDevice
Also called UltraPulse, Lumenis
patients will have serial laser treatments
| Study group | Role | What they receive |
|---|---|---|
| fractionated carbon dioxide laser | Experimental | fractionated carbon dioxide laser Receives: Device: fractionated carbon dioxide laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Pigmentation, Baseline vs 15-months
Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.
Measured: Baseline and 15 months
Scar Elasticity, Baseline vs 15-months
This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.
Measured: Baseline and 15 months
Scar Thickness
This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
Measured: Baseline and 15 months
Secondary outcomes (2)
Quality of Life
The 36-Item Short Form Survey (SF-36) is a validated quality of life measurement tool. It measures 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. It is scored on a 0-100 scale, with 100 being the least bothersome to quality of life.
Measured: Baseline and 15 months
POSAS
The Patient and Observer Scar Assessment Scale (POSAS) is a validated scale that measures both the patient assessment and the observer assessment on the quality (height, color, stiffness, thickness, symptoms, relief, surface area) of the scar. Scores range from 0-60, with 60 being the worst quality of scar.
Measured: Baseline and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children, United States Department of Defense
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- Richard R Anderson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115646
- Sponsor's protocol ID
- 2011P001310
- Status last verified
- May 2018
- First submitted
- 1 Jul 2013
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Miletta N, Siwy K, Hivnor C, Clark J, Shofner J, Zurakowski D, Anderson RR, Lee K, Donelan M. Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Ann Surg. 2021 Dec 1;274(6):e574-e580. doi: 10.1097/SLA.0000000000003576.
PubMed 31469749
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
- ClinicalTrials.gov ID
- NCT02115646
- Acronym / sponsor ID
- 2011P001310
- Conditions
- Burn Scars
- Keywords
- burn, scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children, United States Department of Defense
- Study start
- Dec 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Posted 15 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment.
Detailed description
The primary goal of the study will analyze whether the fractionated carbon dioxide laser can improve other subjective and objective qualities of hypertrophic and/or contracted burn scars with or without involvement of nearby mobile joints.
The investigators hypothesize that fractionated carbon dioxide laser therapy will increase range of motion and improve tissue compliance in all scars overlying a mobile joint that has been limited due to burn scar contracture. In addition, the investigators will evaluate the effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or contracted burn scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fractionated carbon dioxide laser | Experimental | Device: fractionated carbon dioxide laserfractionated carbon dioxide laser |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males and females between 5 and 70 years of age with hypertrophic and/or contracted burn scars with or without involvement of mobile joints. The burn scars must have occurred at least 1 year prior to the date of enrollment.
- Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months, and the scars must be deemed stable for a period of 3 months before initiation of treatment.
- Fitzpatrick skin types I-VI
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements
- Able to understand provide written informed consent
Key exclusion criteria (19 listed)
- Pregnant, intending to become pregnant during the course of the study, less than three months postpartum or less than six weeks after completion of breastfeeding.
- Active tanning, including the use of tanning booths, during the course of the study
- Showing symptoms of hormonal disorders (i.e.: uncontrolled thyroid disease or Polycystic Ovary Syndrome), as per the Investigator's discretion
- Abnormal photosensitivity due to metabolic disorder or due to use of external agents, (drugs, herbs, etc.) within 2 weeks of initial treatment or during the course of the study, except for use of aminolevulinic acid(Levulan®) which requires a washout period of three months
- Prior use of retinoids in treated areas within three months of initial treatment or during the course of the study
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 |
|---|---|---|
| fractionated carbon dioxide laserAlso: UltraPulse, Lumenispatients will have serial laser treatments | Device | fractionated carbon dioxide laser |
Primary outcome
Scar Pigmentation, Baseline vs 15-months
Time frame: Baseline and 15 months
Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.
Scar Elasticity, Baseline vs 15-months
Time frame: Baseline and 15 months
This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.
Scar Thickness
Time frame: Baseline and 15 months
This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.
2 secondary outcomes
Quality of Life
Time frame: Baseline and 15 months
POSAS
Time frame: Baseline and 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31469749Miletta N, Siwy K, Hivnor C, Clark J, Shofner J, Zurakowski D, Anderson RR, Lee K, Donelan M. Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Ann Surg. 2021 Dec 1;274(6):e574-e580. doi: 10.1097/SLA.0000000000003576.
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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.
Richard R Anderson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fractionated carbon dioxide 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 6 inclusion and 19 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 26 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scar Pigmentation, Baseline vs 15-months (time frame: Baseline and 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115646, which also lists 1 linked publication.
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 26 Jun 2018.