Carbon Dioxide Laser Treatment in Burn-related Scarring

Burns Scarring Clinical Trial

Official title:

Carbon Dioxide Laser Treatment in Burn-related Scarring: A Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433664
• Other study ID #: 2013/135
• Status: Completed
• Phase: N/A
• First received: January 6, 2018
• Last updated: February 7, 2018
• Start date: February 20, 2014
• Est. completion date: July 16, 2015

Study information

• Verified date: February 2018
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 16, 2015
• Est. primary completion date: January 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Burns
• Burns Scarring
• Cicatrix

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Western Australia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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