Burns ScarringNCT03433664
Carbon Dioxide Laser Treatment in Burn-related Scarring
A study testing CO2 laser in people with Burns Scarring, run by The University of Western Australia.
Trial summary
This study evaluates the effect effect of ablative fractional CO2 laser (AFCO2L) on burns scar appearance and dermal architecture at 6 weeks and up to 3-years post-treatment. Half of the scar will receive AFCO2L and half the scar will receive standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns Scarring
- What is being tested?
- CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2014to 16 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum burn injury scar area of 10x10cm
- Vancouver Scar Scale (VSS) score of >5
- ≥6 months following injury
- Patient age 18+ years
Who cannot join
- Current pregnancy or lactation
- Patients unable to consent (dementia or another cognitive dysfunction)
- Non-English-speaking patients
- Scars on the face or hand (these anatomical areas were considered to be of significant aesthetic and functional importance and thus excluded from the trial )
About this study
Official title: Carbon Dioxide Laser Treatment in Burn-related Scarring: A Prospective Randomised Controlled Trial
This study evaluates the effect effect of ablative fractional CO2 laser (AFCO2L) on burns scar appearance and dermal architecture at 6 weeks and up to 3-years post-treatment. Half of the scar will receive AFCO2L and half the scar will receive standard care.
Read the detailed description
Ablative fractional CO2 laser (AFCO2L) is emerging as a promising scar treatment for burns patients. Fractionated delivery of CO2 laser treatment leaved columns of undamaged skin to quickly re-epithelialize and has reduced the previously higher risk profile of unfractionated ablative laser delivery in terms of permanent pigmentation changes, higher rates of infection and scarring. The exact mechanisms of CO2 laser action are still unclear, but likely involve a combination of macroscopic ablative fenestration, microscopic thermal collagen alteration and molecular profile alterations.
Use of AFCO2L for scar management is increasing amongst burn clinicians; consensus opinion and several large series have demonstrated safe and effective result, however robust randomised controlled evidence for the efficacy of CO2 laser on burns scarring is still lacking.
- Conditions
- Burns Scarring
- Being tested
- CO2 laser
- Keywords
- CO2 laser, Ablative fractional laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laserDevice
Also called Ablative Fractional CO2 laser
Fractional CO2 laser treatment using the DeepFX setting hand piece (Ultrapulse, Lumenis), performed under general anaesthetic at 4-6 week intervals. All treatments consisted of a single pass of 300Hz, 5% density and 50mJ energy with minimal overlapping
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Each treatment half of the scar received three standardised CO2 laser treatments using the DeepFX setting hand piece (Ultrapulse, Lumenis), performed under general anaesthetic at 4-6 week intervals. All treatments consisted of a single pass of 300Hz, 5% density and 50mJ energy with minimal overlapping. Post-operatively all laser treatment and control zones had emollient applied and silicone dressings which were removed at 48 hours. Further emollient was applied twice daily for 2 weeks to all areas of the scar. Standard care scar management (including silicone, massage and pressure garments) was directed by burn occupational therapists and was continued for all areas of scar. Receives: Device: CO2 laser |
| Control | No intervention | Each control half of the scar received emollient applied twice daily for 2 weeks to all areas of the scar after each treatment. Standard care scar management (including silicone, massage and pressure garments) was directed by burn occupational therapists and was continued for all areas of scar. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Vancouver Scar Scale from baseline at 6 weeks post-final treatment
The Modified Vancouver Scar Scale requires an assessor to rate the patient's scars in 4 domains, each assigning a score to the scar for different qualities (pliability, height, vascularity and pigmentation) from 0 to 4 in pliability and height; and 0 to 3 in vascularity and pigmentation, where 0 is a 'normal' score as close to normal skin as possible and a score of 3 or 4 would indicate a poor outcome, dissimilar to normal skin. The minimum total score is 0 (very good scar) and maximum score is 14 (very bad scar)
Measured: 6 weeks post final treatment
Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment
Patient element of the POSAS scale (Patient and Observer Scar Assessment Scale) version 2.0. The scale asks the patient to rate their scars in 6 domains, each assigning a score to the scar for different qualities (pain, itch, colour, stiffness, thickness irregularity and overall opinion) from 1 to 10, where 1 is a very good score and 10 is a very poor score. The minimum total score is 7 (very good scar) and maximum score is 70 (very bad scar)
Measured: 6 weeks post final treatment
Change in Scar histology from baseline at 6 weeks post-final treatment
3mm punch biopsies from treatment and control segments of scar looking at dermal architecture in terms of collagen fibre thickness and orientation
Measured: 6 weeks post final treatment
Secondary outcomes (4)
Change in Scar histology from baseline at 48-72 hours after the first treatment
3mm punch biopsies from treatment and control segments of scar looking at dermal architecture in terms of collagen fibre thickness and orientation
Measured: 48-72 hours after the first treatment
Change in modified Vancouver Scar Scale from baseline at 2-3 years post-final treatment
The Modified Vancouver Scar Scale requires an assessor to rate the patient's scars in 4 domains, each assigning a score to the scar for different qualities (pliability, height, vascularity and pigmentation) from 0 to 4 in pliability and height; and 0 to 3 in vascularity and pigmentation, where 0 is a 'normal' score as close to normal skin as possible and a score of 3 or 4 would indicate a poor outcome, dissimilar to normal skin. The minimum total score is 0 (very good scar) and maximum score is 14 (very bad scar)
Measured: 2-3 years after the final treatment
Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment
Patient element of the POSAS scale (Patient and Observer Scar Assessment Scale) version 2.0. The scale asks the patient to rate their scars in 6 domains, each assigning a score to the scar for different qualities (pain, itch, colour, stiffness, thickness irregularity and overall opinion) from 1 to 10, where 1 is a very good score and 10 is a very poor score. The minimum total score is 7 (very good scar) and maximum score is 70 (very bad scar)
Measured: 2-3 years after the final treatment
Change in Scar histology from baseline at 2-3 years post-final treatment
3mm punch biopsies from treatment and control segments of scar looking at dermal architecture in terms of collagen fibre thickness and orientation
Measured: 2-3 years after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start20 Feb 2014
- Primary completion16 Jan 2015
- Study completion16 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns ScarringStudies 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
- Parallel groups
- Model description
- Scar area (10x10cm square) randomly assigned a square vector 'map' which split the scar into a control and treatment half along one of 4 vectors: vertical, horizontal, and along both diagonals. The envelope revealing the vector map and treatment zones was opened by the treating laser clinician immediately prior to the first treatment. The same treating clinician performed all laser treatments to minimise inter-user variability.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona M. Wood, The University of Western Australia
- Investigators
- Fiona M Wood, FRACS, Study director, UWA and State Burns Unit WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433664
- Sponsor's protocol ID
- 2013/135
- Status last verified
- Feb 2018
- First submitted
- 6 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide Laser Treatment in Burn-related Scarring: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03433664
- Acronym / sponsor ID
- 2013/135
- Conditions
- Burns Scarring
- Keywords
- CO2 laser, Ablative fractional laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 16 Jan 2015 (actual)
- Study completion
- 16 Jul 2015 (actual)
- First posted
- 14 Feb 2018 (actual)
- 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.
This study evaluates the effect effect of ablative fractional CO2 laser (AFCO2L) on burns scar appearance and dermal architecture at 6 weeks and up to 3-years post-treatment. Half of the scar will receive AFCO2L and half the scar will receive standard care.
Detailed description
Ablative fractional CO2 laser (AFCO2L) is emerging as a promising scar treatment for burns patients. Fractionated delivery of CO2 laser treatment leaved columns of undamaged skin to quickly re-epithelialize and has reduced the previously higher risk profile of unfractionated ablative laser delivery in terms of permanent pigmentation changes, higher rates of infection and scarring. The exact mechanisms of CO2 laser action are still unclear, but likely involve a combination of macroscopic ablative fenestration, microscopic thermal collagen alteration and molecular profile alterations.
Use of AFCO2L for scar management is increasing amongst burn clinicians; consensus opinion and several large series have demonstrated safe and effective result, however robust randomised controlled evidence for the efficacy of CO2 laser on burns scarring is still lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Scar area (10x10cm square) randomly assigned a square vector 'map' which split the scar into a control and treatment half along one of 4 vectors: vertical, horizontal, and along both diagonals. The envelope revealing the vector map and treatment zones was opened by the treating laser clinician immediately prior to the first treatment. The same treating clinician performed all laser treatments to minimise inter-user variability.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CO2 laserEach treatment half of the scar received three standardised CO2 laser treatments using the DeepFX setting hand piece (Ultrapulse, Lumenis), performed under general anaesthetic at 4-6 week intervals. All treatments consisted of a single pass of 300Hz, 5% density and 50mJ energy with minimal overlapping. Post-operatively all laser treatment and control zones had emollient applied and silicone dressings which were removed at 48 hours. Further emollient was applied twice daily for 2 weeks to all areas of the scar. Standard care scar management (including silicone, massage and pressure garments) was directed by burn occupational therapists and was continued for all areas of scar. |
| Control | No intervention | –Each control half of the scar received emollient applied twice daily for 2 weeks to all areas of the scar after each treatment. Standard care scar management (including silicone, massage and pressure garments) was directed by burn occupational therapists and was continued for all areas of scar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum burn injury scar area of 10x10cm
- Vancouver Scar Scale (VSS) score of >5
- ≥6 months following injury
- Patient age 18+ years
Key exclusion criteria (4 listed)
- Current pregnancy or lactation
- Patients unable to consent (dementia or another cognitive dysfunction)
- Non-English-speaking patients
- Scars on the face or hand (these anatomical areas were considered to be of significant aesthetic and functional importance and thus excluded from the trial )
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 |
|---|---|---|
| CO2 laserAlso: Ablative Fractional CO2 laserFractional CO2 laser treatment using the DeepFX setting hand piece (Ultrapulse, Lumenis), performed under general anaesthetic at 4-6 week intervals. All treatments consisted of a single pass of 300Hz, 5% density and 50mJ energy with minimal overlapping | Device | Treatment |
Primary outcome
Change in modified Vancouver Scar Scale from baseline at 6 weeks post-final treatment
Time frame: 6 weeks post final treatment
The Modified Vancouver Scar Scale requires an assessor to rate the patient's scars in 4 domains, each assigning a score to the scar for different qualities (pliability, height, vascularity and pigmentation) from 0 to 4 in pliability and height; and 0 to 3 in vascularity and pigmentation, where 0 is a 'normal' score as close to normal skin as possible and a score of 3 or 4 would indicate a poor outcome, dissimilar to normal skin. The minimum total score is 0 (very good scar) and maximum score is 14 (very bad scar)
Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment
Time frame: 6 weeks post final treatment
Patient element of the POSAS scale (Patient and Observer Scar Assessment Scale) version 2.0. The scale asks the patient to rate their scars in 6 domains, each assigning a score to the scar for different qualities (pain, itch, colour, stiffness, thickness irregularity and overall opinion) from 1 to 10, where 1 is a very good score and 10 is a very poor score. The minimum total score is 7 (very good scar) and maximum score is 70 (very bad scar)
Change in Scar histology from baseline at 6 weeks post-final treatment
Time frame: 6 weeks post final treatment
3mm punch biopsies from treatment and control segments of scar looking at dermal architecture in terms of collagen fibre thickness and orientation
4 secondary outcomes
Change in Scar histology from baseline at 48-72 hours after the first treatment
Time frame: 48-72 hours after the first treatment
Change in modified Vancouver Scar Scale from baseline at 2-3 years post-final treatment
Time frame: 2-3 years after the final treatment
Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment
Time frame: 2-3 years after the final treatment
Change in Scar histology from baseline at 2-3 years post-final treatment
Time frame: 2-3 years after the final treatment
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 14 Feb 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for primary and secondary outcome measures will be made available
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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.
Fiona M Wood, FRACS study director
UWA and State Burns Unit WA
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser in people with Burns Scarring, run by The University of Western Australia.
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 4 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in modified Vancouver Scar Scale from baseline at 6 weeks post-final treatment (time frame: 6 weeks post final treatment). 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?
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 14 Feb 2018.