Clinical trial NCT03433664: Carbon Dioxide Laser Treatment in Burn-related Scarring
Official title: Carbon Dioxide Laser Treatment in Burn-related Scarring: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns Scarring
Keywords: CO2 laser
Ablative fractional laser
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Minimum burn injury scar area of 10x10cm
* Vancouver Scar Scale (VSS) score of \>5
* ≥6 months following injury
* Patient age 18+ years

Exclusion Criteria:

* 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 )

Primary outcomes:
measure: Change in modified Vancouver Scar Scale from baseline at 6 weeks post-final treatment
timeFrame: 6 weeks post final treatment
measure: Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment
timeFrame: 6 weeks post final treatment
measure: Change in Scar histology from baseline at 6 weeks post-final treatment
timeFrame: 6 weeks post final treatment
Secondary outcomes:
measure: Change in Scar histology from baseline at 48-72 hours after the first treatment
timeFrame: 48-72 hours after the first treatment
measure: Change in modified Vancouver Scar Scale from baseline at 2-3 years post-final treatment
timeFrame: 2-3 years after the final treatment
measure: Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment
timeFrame: 2-3 years after the final treatment
measure: Change in Scar histology from baseline at 2-3 years post-final treatment
timeFrame: 2-3 years after the final treatment
Other outcomes:
Locations:
Study officials:
affiliation: UWA and State Burns Unit WA
name: Fiona M Wood, FRACS
role: STUDY_DIRECTOR
References: