Carbon Dioxide Laser Treatment in Burn-related Scarring

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.

Study Overview

• Status: Completed
• Conditions: Burns Scarring
• Intervention / Treatment: Device: CO2 laser

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; 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.	Device: 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; Other Names: Ablative Fractional CO2 laser
NO_INTERVENTION: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	6 weeks post final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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	2-3 years after the final treatment

Collaborators and Investigators

• Sponsor: The University of Western Australia
• Investigators: Study Director: Fiona M Wood, FRACS, UWA and State Burns Unit WA

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2014
• Primary Completion (ACTUAL): January 16, 2015
• Study Completion (ACTUAL): July 16, 2015

Study Registration Dates

• First Submitted: January 6, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: CO2 laser; Ablative fractional laser
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Burns; Cicatrix
• Other Study ID Numbers: 2013/135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Within 6 months of study completion
• IPD Sharing Access Criteria: By liaison with principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes