Carbon Dioxide Laser Treatment in Burn-related Scarring

NCT ID: NCT03433664

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-20
• Study Completion Date: 2015-07-16

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.

Conditions

Burns Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CO2 laser

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Ablative Fractional CO2 laser

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 )

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Western Australia

OTHER

Sponsor Role: lead

Responsible Party

Fiona M. Wood

Head of State Burns Unit WA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona M Wood, FRACS

Role: STUDY_DIRECTOR

UWA and State Burns Unit WA

Other Identifiers

2013/135

Identifier Type: -

Identifier Source: org_study_id