None listed
Conditions
Brief summary
For quality assurance and research, this project aims to evaluate burn scar outcomes following treatment with the Lumenis® UltraPulse® Fractionated CO2 ablative laser at the Royal Adelaide Hospital (RAH). Similar laser therapy is currently available for the paediatric population in SA, however, until recently, there was no access to this treatment for adults in SA. As comparison burn units around Australia and internationally have been successfully using this therapy for over 4 years to improve patient outcomes without negative long-term effects, the RAH Adult Burn Service decided to investigate offering this modality as a scar management option for our patient population. As part of introducing this new procedure, we are interested in evaluating the outcomes to ensure there are meaningful clinical benefits for patients that complement our current scar management. We also aim to add to the research knowledge base by comparing subjective and objective scar properties and outcomes. And finally, we would like to also evaluate patient-reported outcomes and the effect on psycho-social well-being of both laser treated and non-laser treated scars.
Interventions
The Lumenis® UltraPulse® system is a CO2 laser. Light is generated by the excitation of CO2 molecules producing a beam of infrared light. This gives the CO2 laser the chromophore (molecule which it is most active upon) of water. This allows the UltraPulse® system with the use of fractionated columns in a computer-generated pattern to very precisely vapourise (ablate) a small column of tissue no greater than 400um and is faster than the thermal relaxation time of skin to a depth that is adjustabl
The Lumenis® UltraPulse® system is a CO2 laser. Light is generated by the excitation of CO2 molecules producing a beam of infrared light. This gives the CO2 laser the chromophore (molecule which it is most active upon) of water. This allows the UltraPulse® system with the use of fractionated columns in a computer-generated pattern to very precisely vapourise (ablate) a small column of tissue no greater than 400um and is faster than the thermal relaxation time of skin to a depth that is adjustable by manipulating the energy level. The laser produces microscopic thermal injury patterns which initiate tissue remodeling. Compared with burn wounds, which scar, the microscopic wounds created with the laser generally heal without scarring. This process can also result in increased mobility of already present scar tissue. In our study, the laser settings are pre-determined and set out on a table provided by the manufacturer of the laser (Lumenis) with energy settings ranging from 5-50mJ for DeepFX and 50-125mJ for ActiveFx. Scar thickness will be measured with Ultrasound prior to laser treatment in order to accurately determine the appropriate laser settings to reach the required ablative depth. However, surgeon preference resulted in different laser settings being utilized to match clinical judgement of the most appropriate settings. This device works by vaporising tissue and like any other device which can cause tissue destruction (such as a scalpel blade), it needs to only be used by a trained professional with the skills and knowledge to avoid harm to patient, operator and staff. At our facility, this will be a surgeon and will be in an operating theatre. Typically general anaesthesia is utilised but if the areas are small a local anaesthetic may be more appropriate. Participants may in the course of the study receive more than one laser session no less than 6 weeks apart if they do not obtain the desired outcome within one session. Typically more than one session is required, with three sessions being the usual maximum to obtain the desired outcome. Each session date is recorded on the data entry spreadsheet. Post-laser the patient may return to scar management techniques such as pressure garments and this will be noted in follow up outcome assessment sessions. Other than this the only other instructions patients are provided with is to comply with early wound care and ongoing sun protection.
Sponsors
Dr Marcus Wagstaff
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who consent to laser treatment 18 years – 80 years Burns scars with functional (e.g. itch, pain, contracture, limiting range of motion) and/or cosmetic impairment (e.g. pigmentation) Patients whose scars have been assessed by a clinician as appropriate for laser management to improve scar outcome.
Exclusion criteria
Inability to provide consent – psychiatric or medical comorbidity Active infections Previous radiation treatment to the laser treatment area (i.e. Radiotherapy) Pregnancy or lactation Patients who are taking part in any other trial that may affect the outcome Complex locations e.g. eyelids; ears; lips; genitals (difficulties with scar Ax) Lumenis® CO2 laser is contraindicated where a patient has taken Accutane (Isotretinoin) within the past 6-12 months, Has a history of keloid formation and demonstrate excessive or unusually prolonged erythema.
Outcome results
None listed