Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Carbon Dioxide Laser Treatment in Burn-related Scarring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433664
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fiona M. Wood, The University of Western Australia

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.

Condition or disease Intervention/treatment Phase
Burns Scarring Device: CO2 laser Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Patient and treating clinician were aware of which scar half had been treated, however investigator and assessor were blinded
Primary Purpose: Treatment
Official Title: Carbon Dioxide Laser Treatment in Burn-related Scarring: A Prospective Randomised Controlled Trial
Actual Study Start Date : February 20, 2014
Actual Primary Completion Date : January 16, 2015
Actual Study Completion Date : July 16, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

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 Name: 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.



Primary Outcome Measures :
  1. Change in modified Vancouver Scar Scale from baseline at 6 weeks post-final treatment [ Time Frame: 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)

  2. Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment [ Time Frame: 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)

  3. Change in Scar histology from baseline at 6 weeks post-final treatment [ Time Frame: 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


Secondary Outcome Measures :
  1. Change in Scar histology from baseline at 48-72 hours after the first treatment [ Time Frame: 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

  2. Change in modified Vancouver Scar Scale from baseline at 2-3 years post-final treatment [ Time Frame: 2-3 years after the 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)

  3. Change in Patient Scar Assessment Scale (patient element of the POSAS scale) from baseline at 6 weeks post-final treatment [ Time Frame: 2-3 years after the 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)

  4. Change in Scar histology from baseline at 2-3 years post-final treatment [ Time Frame: 2-3 years after the final treatment ]
    3mm punch biopsies from treatment and control segments of scar looking at dermal architecture in terms of collagen fibre thickness and orientation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433664


Sponsors and Collaborators
The University of Western Australia
Investigators
Layout table for investigator information
Study Director: Fiona M Wood, FRACS UWA and State Burns Unit WA

Layout table for additonal information
Responsible Party: Fiona M. Wood, Head of State Burns Unit WA, The University of Western Australia
ClinicalTrials.gov Identifier: NCT03433664     History of Changes
Other Study ID Numbers: 2013/135
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Within 6 months of study completion
Access Criteria: By liaison with principal investigator

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Fiona M. Wood, The University of Western Australia:
CO2 laser
Ablative fractional laser
Additional relevant MeSH terms:
Layout table for MeSH terms
Cicatrix
Burns
Wounds and Injuries
Fibrosis
Pathologic Processes