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Trial registered on ANZCTR


Registration number
ACTRN12618001227280
Ethics application status
Approved
Date submitted
25/06/2018
Date registered
20/07/2018
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Silicone film forming dressing versus standard care for the treatment of acute burn injuries including burn injuries not requiring surgery and donor sites.
Scientific title
The efficacy of silicone film forming dressing versus standard care for the treatment of acute burn injuries not requiring surgery and donor sites.
Secondary ID [1] 295298 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn wounds 308491 0
Donor sites 308492 0
Condition category
Condition code
Skin 307469 307469 0 0
Other skin conditions
Injuries and Accidents 307763 307763 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this research. The first arm will study Stratamed on facial burn wounds and the second arm will study StrataXRT on donor site wounds. Stratamed and StrataXRT are different products but are both silicone based wound care products.

Research Arm 1: Stratamed - a topical silicone film forming dressing that will be used in face burn wounds not requiring surgery.
1) A thin layer of topical silicone gel will be smeared over the entire facial burn wounds for those patients randomised to the intervention group. For those randomised to the control group they will follow the same dressing protocol using emollient on the face burn wounds.
2) In between dressing appointments and when at home, these patients will be required to wash their face wounds every morning and every evening, and reapply another thin layer of topical silicone or emollient every 2 hours when at home and in between dressing appointments.
3) The patients will need to attend dressing clinics for wound reviews within the following schedule. Day 2-5, day 5-7, day 7-10 and day 10-14. Clinics are not open on public holidays and on weekends so follow up appointments need to be made within the ranges of days as above.
4) When attending dressing appointments a nurse will assist the patient with washing their face wounds. The researcher will arrange clinical photography of the face burn wounds. The nurse will then assist with reapplying another layer of topical silicone gel or emollient as per the allocation group - intervention or control. The patient will be alert and will be seated.
5) Once the burn wound has had the topical silicone or emollient reapplied they will be asked to complete outcome measures including a Visual Analogue Sclae (VAS) pain scale and pain questionnaire.
6) The primary research investigator will liaise with and observe nursing staff during interventions to ensure that participants remain in the same allocated control or intervention group and the same dressing protocol and application is adhered to. The researcher will not complete any interventions or take outcome measures.
7) A different nurse (blinded) will assess if the wounds are fully healed. Once healed the patients will no longer be required to apply the topical silicone or emollient and will be advised by the treating Occupational Therapist on caring for healed skin.
8) The participants will attend clinic appointments at 6 weeks and 3 months post burn injury for routine scar assessments. At these same appointments outcome measures for scarring will be completed including clinical photography, patient POSAS questionnaire, dermalab measures (pigment and vascularity) and Vancouver Scar Scale (VSS) assessment.

Research Arm 2: StrataXRT - a topical silicone film forming dressing that will be used on donor sites. The participants will have two donor sites which will be randomised to either the control or intervention. So the same participant will have two donor sites, of which one will be the control and the other will be the intervention donor site.

1) Randomisation will occur at the point of surgery in theatre. The donor site that has been randomised to the intervention group will receive a a thin layer of topical silicone gel (StrataXRT) to the dressing. The StrataXRT gel will be smeared over the dressing before being applied to the intervention donor site wound. The control donor site will have the same dressing but it will not have a layer of gel applied to it.
2) The same type of dressings will be used at each dressing change until the donor site wounds are healed. This will be an Algisite and fixomull dressing and will be applied at baseline in theatre. Both both donor sites will receive the same dressing but only the intervention donor site will have the topical silicone smeared over its dressing.
3) The patients will need to attend dressing clinics for dressing changes within the following schedule. Day 2-5, day 5-7, day 7-10 and day 10-14. Attendance can only occur during week days as dressing clinics are not open weekends and public holidays. The donor site dressing will need to remain intact for 5 days, however, this can be changed earlier if the dressing has significantly leaked or if day 5 falls over a weekend or public holiday. Therefore the day of the week the donor site dressing will next be changed is determined by the day of surgery (when the donor site wound is created).
4) Donor site wounds will be changed by a nurse with the patient alert and lying down in the clinic room. The donor site wound will be the first dressing to be changed before any other burn wound or graft the patient might have.
5) Once the burn donor site dressing is removed and cleaned, photographs will be completed by clinical photography. The donor site wounds can then be re-dressed with a clean dressing. StrataXRT will continue to be applied the dressing for the intervention donor site, and a clean Algisite and fixomull dressing will be reapplied to both donor sites. The patient will then be asked to complete outcome measures including VAS pain scale and questionnaire. Any other burns wounds or dressings can then be re-dressed.
6) The patient will continue to attend appointments for donor site dressing changes and outcome measures until an independent nurse assessor confirms the donor site wounds are healed. Once healed the patients will no longer be required to apply the topical silicone or any further dressings to the donor sites.
7) At 6 weeks and 3 months post burn injury outcome measures for scarring will be completed at follow up clinic appointments. Outcome measures will be completed by research assistants or Occupational Therapists (both blinded) and include clinical photography, patient POSAS, dermalab measures (pigment and vascularity) and VSS.
8) The primary research investigator will liaise with and observe nursing staff to ensure that participants remain in the same allocated control or intervention group and the same dressing protocol and application is adhered to.


Intervention code [1] 301633 0
Treatment: Drugs
Comparator / control treatment
First arm - burn wounds not requiring surgery (faces), will receive standard care which is topical emolient.
Second arm - donor sites, will receive standard care which is an algisite and fixomull dressing.
The timing of appointments for dressing changes for faces and donor sites, and the 6 week and 3 months scar review appointments are all standard care for all burns patients.
Control group
Active

Outcomes
Primary outcome [1] 306442 0
Time to healing will be assessed by a blinded clinical nurse. Clinical photography using an angled ruler of face and donor site wounds will be completed at each dressing change. The blinded nurse will then measure the percentage healed and record this following each dressing change appointment. The wound will be considered healing once wounds are fully epithelialised and the nurse determines that no further dressings are required.
Timepoint [1] 306442 0
Baseline will be first presentation to dressing clinic for face burns in arm 1, and in study arm 2 baseline will be the point of surgery. Dressing changes and outcome measures will be completed subsequently at, days 2-5, days 5-7, days 7-10 and days 10-14 after intervention commencement. The same nurse will complete wound assessments and determine percentage of wound healing through clinical photography with an angled ruler following each dressing appointment which could fall within the above ranges.
Primary outcome [2] 306443 0
Pain will be assessed at the conclusion of dressing changes for face burns and donor sites at each clinic appointment. A blinded research assistant or Occupational Therapist will get the participant to complete a Visual Analogue Scale for pain. A brief questionnaire designed specifically for this study will also be completed with the patient. This consists of 4 questions. Do you donor sites hurt? Is site A worse than B? Is site A better than B? Does it all feel the same?.
Timepoint [2] 306443 0
For the first arm with face burns, baseline will be first presentation to dressing clinic. for donor sites the second arm, baseline will be the point of surgery. Outcome measures will be completed at subsequent dressing changes with time point 1 from day 2 to 5 (depending on which day of the week they are returning to clinic), time point 2 from day 5 to 7, time point 3 from day 7 to 10 and time point 4 from day 10 to 14 after intervention commencement. The same VAS pain scale and questionnaire will be completed at the same timepoints i.e. at each dressing change appointment.
The end point will be the date recorded as the day the wound is healed.
Secondary outcome [1] 348562 0
This is a composite secondary outcome specifically assessing scarring outcomes at 6 weeks and 3 months. Several outcomes measures will be completed at the same time to the same healed areas.
1) The patient POSAS questionnaire will be completed by the patient, and a blinded researcher or OT will complete dermalab measures and the VSS. at the same points for the face and donor sites.
2) All participants (both intervention and control groups) for both arms of the study, 1) Faces and 2) Donor sites will have 2 points of healed areas identified for specific testing with the Dermalab and VSS. This will be the first point healed and the last point healed - this will be identified by the blinded clinical nurse and recorded during the wound healing phase at dressing changes.
3) A blinded research assistant or OT will take dermalab recordings and VSS measures in the same clinic appointments. The dermalab uses probes to measure the characteristics of scarring. This study will only use the Dermalab to measure vascularity and pigmentation. The recording provides a numbered reading. The VSS will be completed by a blinded Occupational Therapist on the same testing points. The VSS is a scale completed by a blinded OT to measure pigmentation, vascularity, pliability and height.
Timepoint [1] 348562 0
Six weeks and three months after intervention commencement.

Eligibility
Key inclusion criteria
First arm:
Adults 18-65 years of age
Burns <15% Total Body Surface Area (TBSA)
Burns not requiring surgical intervention

Second Arm:
Adults 18-65 years of age
Burn < 15% TBSA
Donor site > 1%
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
First Arm:
Burn > 15% TBSA
Burn requiring surgical intervention
Aged below 18 years or older than 65 years
Diabetes
Neuropathy
Vascular abnormality
Pre-existing dermalogical condition
Pregnant women
Infection
Late presentations over 1/52

Second Arm:
All of the above but excluding 'burns requiring surgical intervention'.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
First arm will be parallel in that there will be two different groups - one will receive the intervention (silicone dressing) and the other group will be the control (standard care using emolient).

Second arm will be cross over in that the same patient will have two donor sites which will be randomised so one donor site will be the control and the other will be the intervention (receiving silicone).
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Statistics:
Descriptive, univariate statistics will be used to describe the general characteristics of the sample. 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. The statistical package (SPSS) program will be used.

Sample Size:
We are proposing a sample size of 90 patients (First Arm - 30 intervention and 30 control, Second Arm - 30 donor sites). To detect a standardised difference of 1.58 between the two groups with 80% power and a significance set at 0.05 then 90 subjects are needed in total.

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] 11225 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 23098 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 299892 0
Commercial sector/Industry
Name [1] 299892 0
Stratpharma AG
Address [1] 299892 0
Stratpharma AG
Centralbahnplatz 8
4051 Basel, Switzerland
Country [1] 299892 0
Switzerland
Primary sponsor type
Charities/Societies/Foundations
Name
Fiona Wood Foundation
Address
Fiona Wood Foundation
Level 4
State Adult Burns Unit
102-118 Murdoch Drive
Murdoch, Perth
WA 6150
Country
Australia
Secondary sponsor category [1] 299252 0
Hospital
Name [1] 299252 0
Fiona Stanley Hospital
Address [1] 299252 0
State Adult Burns Unit
Level 4
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch, WA 6150
Country [1] 299252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300761 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 300761 0
South Metropolitan Health Service Human Research Ethics Committee
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA 6150
Ethics committee country [1] 300761 0
Australia
Date submitted for ethics approval [1] 300761 0
16/05/2017
Approval date [1] 300761 0
16/02/2018
Ethics approval number [1] 300761 0
RGS0000000027

Summary
Brief summary
The aim of this research is to obtain high quality data on the impact of the early application of film forming silicones on burn injuries and donor sites. Objectives include time to healing, patients perceived pain and scar outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84726 0
Mrs Fiona Poelchow
Address 84726 0
Fiona Wood Foundation
Fiona Stanley Hospital
CD15, Level 4, Burns Unit
11 Robin Warren Dve
Murdoch WA 6150

Country 84726 0
Australia
Phone 84726 0
+61 8 6152 0307
Fax 84726 0
Email 84726 0
fiona.poelchow@health.wa.gov.au
Contact person for public queries
Name 84727 0
Mrs Fiona Poelchow
Address 84727 0
Fiona Wood Foundation
Fiona Stanley Hospital
CD15, Level 4, Burns Unit
11 Robin Warren Dve
Murdoch WA 6150

Country 84727 0
Australia
Phone 84727 0
+61 8 6152 0307
Fax 84727 0
Email 84727 0
fiona.poelchow@health.wa.gov.au
Contact person for scientific queries
Name 84728 0
Mrs Fiona Poelchow
Address 84728 0
Fiona Wood Foundation
Fiona Stanley Hospital
CD15, Level 4, Burns Unit
11 Robin Warren Dve
Murdoch WA 6150

Country 84728 0
Australia
Phone 84728 0
+61 8 6152 0307
Fax 84728 0
Email 84728 0
fiona.poelchow@health.wa.gov.au

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