Trials / Completed
CompletedNCT03433664
Carbon Dioxide Laser Treatment in Burn-related Scarring
Carbon Dioxide Laser Treatment in Burn-related Scarring: A Prospective Randomised Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- The University of Western Australia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-02-20
- Primary completion
- 2015-01-16
- Completion
- 2015-07-16
- First posted
- 2018-02-14
- Last updated
- 2018-02-14
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03433664. Inclusion in this directory is not an endorsement.