Carbon Dioxide Laser Treatment in Burn-related Scarring

NCT03433664 | Completed FDA Device

• 1 other identifier: 2013/135
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burns Scarring

Keywords

CO2 laser; Ablative fractional laser

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Scar histology from baseline at 48-72 hours after the first treatment

  48-72 hours after the first treatment

• Change in modified Vancouver Scar Scale from baseline at 2-3 years post-final treatment

  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

  2-3 years after the final treatment

• Change in Scar histology from baseline at 2-3 years post-final treatment

  2-3 years after the final treatment

Study Arms (2)

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.

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.

Interventions

CO2 laser DEVICE

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

Also known as: Ablative Fractional CO2 laser

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• The University of Western Australia: lead

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Fiona M Wood, FRACS

  UWA and State Burns Unit WA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient and treating clinician were aware of which scar half had been treated, however investigator and assessor were blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of State Burns Unit WA

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: February 14, 2018
• Study Start: February 20, 2014
• Primary Completion: January 16, 2015
• Study Completion: July 16, 2015
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months of study completion
• Access Criteria: By liaison with principal investigator