Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001071910
Ethics application status
Approved
Date submitted
15/07/2020
Date registered
19/10/2020
Date last updated
25/02/2024
Date data sharing statement initially provided
19/10/2020
Date results provided
25/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of scar outcomes after treatment of burn scars with fractionated CO2 ablative laser
Scientific title
Evaluation of subjective and objective scar outcomes post treatment of burn scars with fractionated CO2 ablative laser.
Secondary ID [1] 301666 0
Nil known
Universal Trial Number (UTN)
U1111-1254-5213
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic scar 318099 0
Burn scar 318100 0
Burn scar contracture 318101 0
Burn scar cosmesis 318102 0
Condition category
Condition code
Skin 316123 316123 0 0
Other skin conditions
Injuries and Accidents 316125 316125 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317977 0
Treatment: Surgery
Comparator / control treatment
Where able, an untreated comparison scar will be utilized, whereby it will be assessed in the same manner as the treated scars. The control is no CO2 laser treatment on this comparator scar. The control scar is to be located in a similar location on the contralateral side, be of similar appearance and/or be located at a practical distance far enough away from the lasered site so as to not be affected by the laser procedure. Although there are no prior studies to indicate how much is a suitable distance away from the treated scar the location should be at least not in the region that scar release is expected to negate the effects of changes in mechanotransduction.
Control group
Active

Outcomes
Primary outcome [1] 324319 0
Changes in scar parameters will be assessed with composite scores of scar scales. These are considered as "subjective" as they rely on the observations of the assessor and do not use instrumentation. The Matching Assessment using Photographs with Scars (MAPS) and the Patient and Observer Scar Assessment Scale v2.0/EN - Observer (POSAS-O) assess the scar parameters of height, colour, pliability, texture and pigmentation.
Timepoint [1] 324319 0
These assessments are completed within one week pre-laser intervention. Then will be at 1month, 3months, 6 months and 12 months post-laser intervention. There is no primary endpoint as all data points are useful in analysis of how the scar performs not only in the early stages but over a prolonged period.
Primary outcome [2] 324320 0
Changes in scar elasticity utilising the DermaLab® elasticity probe.
Timepoint [2] 324320 0
This assessment is completed within one week pre-laser intervention. Then will be at 1month, 3months, 6 months and 12 months post-laser intervention. There is no primary endpoint as all data points are useful in analysis of how the scar performs not only in the early stages but over a prolonged period.
Primary outcome [3] 324891 0
Objective changes in scar colour utilising the DermaLab® skin colour probe.
Timepoint [3] 324891 0
This assessment is completed within one week pre-laser intervention. Then will be at 1month, 3months, 6 months and 12 months post-laser intervention. There is no primary endpoint as all data points are useful in analysis of how the scar performs not only in the early stages but over a prolonged period.
Secondary outcome [1] 384310 0
Objective changes in Range of Movement (ROM) will be measured using goniometer or computerized goniometry (e-Link). Positioning for measurement of ROM will follow the "Scar Goniometry" guidelines. Motions to be measured will be those that are expected to change as a result of close proximity to the laser intervention site. For example a laser site on the posterior axillary fold may result in changes in shoulder flexion.
Timepoint [1] 384310 0
This assessment is completed within one week pre-laser intervention. Then will be at 1month, 3months, 6 months and 12 months post-laser intervention.
Secondary outcome [2] 384311 0
Changes in surgical reconstruction practices will be examined by asking the assessing surgeon prior to laser treatment "what would be the usual reconstruction procedure, if any, if the laser was not available".
Timepoint [2] 384311 0
At the time of the reconstruction clinic appointment where recruitment and planning of the laser procedure occurs. Depending on the participant's availability and the organisation's capacity this may occur within 2 months of the actual laser procedure date. Any longer than 2 months would warrant re-assessment of the site to ensure the laser treatment proposed is still appropriate.
Secondary outcome [3] 384312 0
Changes in distress regarding burn scar as measured by DAS24 (Derriford Appearance Scale)
Timepoint [3] 384312 0
The DAS is to be administered within 1 week Pre-laser. It is then to be administered at 6months and 12 months post the laser intervention.
Secondary outcome [4] 384313 0
Changes in transepidermal water loss (TEWL) are to be measured utilising a Vapometer (Delphin Industries) and DermaLab® TEWL probe.
Timepoint [4] 384313 0
This assessment is completed within one week pre-laser intervention. Then will be at 1month, 3months, 6 months and 12 months post-laser intervention.
Secondary outcome [5] 387209 0
Changes in scar thickness are to be measured with the Dermalab(R) Standard Ultrasound probe.
Timepoint [5] 387209 0
This assessment is completed within one week pre-laser intervention. Then will be at 1month, 3months, 6 months and 12 months post-laser intervention.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients are all receiving laser however the settings of the laser for each individual scar are determined according to the thickness of the scar as measured by Ultrasound. Therefore the laser settings will vary for each individual.
Comparisons with the control scar will involve completing all the same assessments that have been performed the treated scars (eg MAPS, POSAS-O & -P, Ultrasound, TEWL, Colour, Elasticity).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous variables will be compared using Student’s t-test, Wilcoxon rank sum test, one-way analysis of variance (ANOVA) and the Kruskal–Wallis test where appropriate. Where necessary, log2 transformation of continuous data will be performed to achieve normal distribution for these analyses.
Differences between proportions derived from categorical data will be analyzed using Pearson’s chi-squared test or Fisher’s exact test where appropriate. Descriptive presentation of data will also be employed to assist visualization where alternate statistical analyses are inappropriate. Where sufficient patient numbers are recruited, comparisons between scar assessment tools will be made to assess for agreement as an exploratory outcome between the two tools employed as part of this study.
Power calculations have not been implemented due to the inability to obtain statistical support prior to the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/06/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
2/11/2021
Date of last data collection
Anticipated
30/07/2022
Actual
14/03/2023
Sample size
Target
20
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17017 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 30684 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 306100 0
Charities/Societies/Foundations
Name [1] 306100 0
The hospital research foundation group
Country [1] 306100 0
Australia
Primary sponsor type
Hospital
Name
Dr Marcus Wagstaff
Address
Department of Plastic & Reconstructive Surgery
Royal Adelaide Hospital
1 Port Rd
Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 306579 0
None
Name [1] 306579 0
Address [1] 306579 0
Country [1] 306579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306319 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306319 0
Ethics committee country [1] 306319 0
Australia
Date submitted for ethics approval [1] 306319 0
02/05/2020
Approval date [1] 306319 0
13/05/2020
Ethics approval number [1] 306319 0
HREC/18/CALHN/361 CALHN Reference number: R20180605

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103490 0
Dr Marcus Wagstaff
Address 103490 0
Department of Plastic & Reconstructive Surgery
Royal Adelaide Hospital
1 Port Rd
Adelaide SA 5000
Country 103490 0
Australia
Phone 103490 0
+61 8 70742404
Fax 103490 0
Email 103490 0
[email protected]
Contact person for public queries
Name 103491 0
Marcus Wagstaff
Address 103491 0
Department of Plastic & Reconstructive Surgery
Royal Adelaide Hospital
1 Port Rd
Adelaide SA 5000
Country 103491 0
Australia
Phone 103491 0
+61 8 70742404
Fax 103491 0
Email 103491 0
[email protected]
Contact person for scientific queries
Name 103492 0
Marcus Wagstaff
Address 103492 0
Department of Plastic & Reconstructive Surgery
Royal Adelaide Hospital
1 Port Rd
Adelaide SA 5000
Country 103492 0
Australia
Phone 103492 0
+61 8 70742404
Fax 103492 0
Email 103492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified background information on participants and results data obtained can be shared.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Case by case basis. However, expect that it will predominantly be available to other researchers.
Available for what types of analyses?
Data may be utilised for any purpose.
How or where can data be obtained?
Access subject to approval by the Principal Investigator via email ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8379Study protocol  [email protected]
8380Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.