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Trial registered on ANZCTR


Registration number
ACTRN12616000343404p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2016
Date registered
16/03/2016
Date last updated
16/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can early intervention with CO2 laser therapy promote scar maturation following a burn injury?
Scientific title
Can early intervention with CO2 laser therapy promote scar maturation following a burn injury?
Secondary ID [1] 288669 0
Nil
Universal Trial Number (UTN)
U1111-1180-2398
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn injury 297862 0
Scar 297863 0
Condition category
Condition code
Skin 298036 298036 0 0
Other skin conditions
Injuries and Accidents 298037 298037 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10,600nm fractional carbon dioxide laser supplied by Lumenis Ltd is the device to be used in this study. This laser has FDA approval for over 100 applications including the management of scars. It has the ability to deliver precise high energy in short-pulses to thickened scars, and has a good record for safety and outcomes. Participants will receive 3 laser treatments 4- 6 weeks apart. The timing of procedures is dependent on patient availability and availability of surgical capacity (ie space on theatre list). Each treatment session lasts between 5 and 15 minutes, depending on the size treated. The patient will receive either a general or local anesthetic prior to the procedure. The choice of anesthetic is at the patient's discretion. The treatments are delivered in a laser safe environment - either in the operating theatre or the laser treatment room on the burns unit. The area to be treated is determined by the surgeon and the patient before the procedure. The laser treatment is delivered by the burn surgeon who is trained in the use of laser therapies and holds a current laser licence. Outcome measures will be conducted before laser treatment, after the third (last) treatment of laser and 3 months after the third laser treatment.
Intervention code [1] 294086 0
Treatment: Devices
Intervention code [2] 294142 0
Treatment: Surgery
Comparator / control treatment
Patients with 2 or more non-contiguous discrete burn areas will be recruited into this study. Each patient will act as their own control. Scar sites will be numbered and each site will be allocated to either LASER (L) or CONTROL (C) treatment regimes. A minimum of two sites are required in each patient. For patients with more than two eligible sites, the most closely matched pair in appearance (based on Vancouver Scar Scale) will be selected. These two scars will then be randomly allocated as the LASER (L) or CONTROL (C) scar. The participant will be unaware of the treated site
Control group
Active

Outcomes
Primary outcome [1] 297551 0
To determine the effect of CO2 laser treatment on the clinical outcome of burn scars versus standard scar therapy. This will be assess using scar assessment measures: Vancouver Scar Scale( VSS) and Patient and Observer Scar Assessment Scale (POSAS)
Timepoint [1] 297551 0
3 months post 3rd laser treatment
Secondary outcome [1] 321395 0
Time in pressure garments assessed by medical records.
Timepoint [1] 321395 0
3 months post 3rd laser treatment
Secondary outcome [2] 321587 0
Need for reconstructive surgery assessed by medical records.
Timepoint [2] 321587 0
3 months post 3rd laser treatment.

Eligibility
Key inclusion criteria
Adults > 18 years of age
Two or more non-contiguous discrete burn areas
Each burn > 1% TBSA
Scars which would ordinarily be managed by pressure garments
All patients to be at least 3 months from burn injury
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or lactating females,
Facial scars
Keloid scars
Inability to give informed consent
Systemic glucocorticoid use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each patient will act as their own control. Scar sites will be numbered and each site will be allocated to either LASER (L) or CONTROL (C) treatment regimes. A minimum of two sites are required in each patient. For patients with more than two eligible sites, the most closely matched pair in appearance (based on Vancouver Scar Scale) will be selected. These two scars will then be randomly allocated as the LASER (L) or CONTROL (C) scar.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive, univariate statistics will be used to describe the general characteristics of the sample. Each patient serves as their own control, and no assumptions will be made regarding the distribution of the data. Hence, differences between “Control” and “Intervention” areas will be examined using the Wilcoxon Signed Rank test, and a p value < 0.05 will be considered to indicate statistical significance. All statistical analysis will be conducted using the statistical package for social sciences (SPSS) program (version 17.0) and STATA. There is no information in the literature on which to base an accurate or meaningful sample size calculation. We are proposing the conventional sample size of 20 patients for a pilot study. This will provide sufficient information to enable an accurate sample size correction for use in a larger trial should a benefit be observed. If no benefit is seen to occur, then we can calculate the probability of having missed a potential benefit in our trial. This data will therefore inform the decision as to whether a future larger trial is warranted, or whether it would be a futile endeavour

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5376 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 12829 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 293030 0
Government body
Name [1] 293030 0
WA Health Department SHRAC Grant
Address [1] 293030 0
189 Royal St, East Perth WA 6004
Country [1] 293030 0
Australia
Primary sponsor type
Individual
Name
Prof Suzanne Rea
Address
State Adult Burns Unit
Level 4
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch, Perth, WA
6150
Country
Australia
Secondary sponsor category [1] 291805 0
Charities/Societies/Foundations
Name [1] 291805 0
Fiona Wood Foundation
Address [1] 291805 0
State Adult Burns Unit
Level 4,
Fiona Stanley Hospital,
102-118 Murdoch Drive
Murdoch, WA,
6150
Country [1] 291805 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294541 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 294541 0
Level 2, Southern Research Facility (Perkins Building) Fiona Stanley Hospital,11 Robin Warren Drive, MURDOCH WA 6150, Western Australia
Ethics committee country [1] 294541 0
Australia
Date submitted for ethics approval [1] 294541 0
26/11/2016
Approval date [1] 294541 0
Ethics approval number [1] 294541 0

Summary
Brief summary
In high income countries, improvements in first aid and acute specialised care have resulted in reduced mortality from major burn injuries (from approximately 25% to less than 9%). Although specialised care has significantly improved outcomes for these patients, the near universal complication of burn-related scarring persists as a constant reminder of limitations of care. For burn survivors, the development of painful, restrictive and disfiguring scarring, known as hypertrophic scarring (HS), has an incidence ranging from 30-70% in reviewed epidemiological data. The treatment of scarring has, thus far, been unable to keep pace with the advancements in resuscitation and other acute therapies. The consequences of scar formation are many and varied, including joint contractures and stiffness, chronic pain, itching, and anhydrosis. Additionally, the emotional repercussions can be significant, with many patients reporting stigmatization and discrimination due to their burn scars. As the mortality of acute burn injury continues to diminish, the burden of scarring may continue to rise. Current treatment options for hypertrophic scarring are not yet sufficient to significantly reduce its associated morbidity. Burn clinicians and researchers are focused on understanding scarring in more depth and discovering potential ways to improve patient outcomes. Within this field of innovation, laser resurfacing techniques are gaining greater interest and are currently being utilised in several centres worldwide for the treatment of HS.

The aim of this study is to investigate if the early use of laser treatment helps minimise scar, decreases the time required in pressure garments, improves range of motion and thus results in fewer episodes of expensive reconstructive surgery.

A 10,600nm fractional carbon dioxide laser supplied by Lumenis Ltd is the device to be used in this study. This laser has FDA approval for over 100 applications including the management of scars. It has the ability to deliver precise high energy in short-pulses to thickened scars, and has a good record for safety and outcomes. The Burns Service of WA has been using this laser for over 18 months for the management of scars, and the health professionals involved have received the appropriate safety training.

Participants will receive 3 laser treatments 4-6 weeks apart. Outcome measures will be conducted before laser treatment, after the last treatment of laser and 3 months post laser treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64054 0
Prof Suzanne Rea
Address 64054 0
State Adult Burns Unit
Level 4
Fiona Stanley Hospital
102 -118 Murdoch Drive
Murdoch, Perth, WA
6150
Country 64054 0
Australia
Phone 64054 0
+61 413 827 186
Fax 64054 0
Email 64054 0
suzanne.rea@health.wa.gov.au
Contact person for public queries
Name 64055 0
Prof Suzanne Rea
Address 64055 0
State Adult Burns Unit
Level 4
Fiona Stanley Hospital
102 -118 Murdoch Drive
Murdoch, Perth, WA
6150
Country 64055 0
Australia
Phone 64055 0
+61 413 827 186
Fax 64055 0
Email 64055 0
suzanne.rea@health.wa.gov.au
Contact person for scientific queries
Name 64056 0
Prof Suzanne Rea
Address 64056 0
State Adult Burns Unit
Level 4
Fiona Stanley Hospital
102 - 118 Murdoch Drive
Murdoch, Perth, WA
6150
Country 64056 0
Australia
Phone 64056 0
+61 413 827 186
Fax 64056 0
Email 64056 0
suzanne.rea@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results