Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000127000
Ethics application status
Approved
Date submitted
3/02/2010
Date registered
8/02/2010
Date last updated
21/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Do pressure garments help burn donor sites to heal?
Scientific title
Interim pressure garment therapy (4–6 mmHg) and its effect on donor site healing in burn patients: a randomised controlled trial
Secondary ID [1] 1370 0
'None'
Universal Trial Number (UTN)
U1111-1113-5601
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns: Scarring of donor sites 256740 0
Compression Garment Therapy 256741 0
Condition category
Condition code
Injuries and Accidents 256897 256897 0 0
Burns
Skin 256898 256898 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Elastic bikepants will be fitted at day 5 following surgery, and replace every 2 weeks for a period of 3 months.
The pressure in each pair of bikepants will be measured at these times.
Intervention code [1] 255960 0
Treatment: Devices
Comparator / control treatment
The control group will not have Elastic bikepants or equivalent.
Control group
Active

Outcomes
Primary outcome [1] 257766 0
Mean donor scar skin thickness (Dermascan C Ultrasound )
Timepoint [1] 257766 0
Measured at day 5, then every fortnight for a period of 3 months.
Primary outcome [2] 257767 0
Reduction of time to epitheleisation (Dermascan C ultrasound)
Timepoint [2] 257767 0
Measured at day 5, then every fortnight for a period of 3 months.
Secondary outcome [1] 263159 0
pressure in the elastic bikepants of >/= 15mmHg (Pico Press Pressure Sensor)
Timepoint [1] 263159 0
Measured at day 5, then every fortnight after for a period of 3 months.
Secondary outcome [2] 263160 0
Improvement of overall scar appearance (Patient Observer Scar Assessment Scale (POSAS))
Timepoint [2] 263160 0
Day 5, then every fortnight for a period fo 3 months
Secondary outcome [3] 263161 0
Reduction in self reported pain level
(Patient Observer Scar Assessment Scale (POSAS))s
Timepoint [3] 263161 0
Day 5, then every fortnight for a period fo 3 months
Secondary outcome [4] 263162 0
Skin type (Fitzpatricks Skin Phototype)
Timepoint [4] 263162 0
Initial assessment day 5 post op.
Secondary outcome [5] 263163 0
Erythema (redness) of skin (Colourmeter)
Timepoint [5] 263163 0
Day 5, then every fortnight for a period fo 3 months
Secondary outcome [6] 263164 0
normal skin comparison on same leg, anatomically close to donor site.
Timepoint [6] 263164 0
Day 5, then every fortnight for a period fo 3 months.

Eligibility
Key inclusion criteria
No burns to either thigh right or left,
Donor site on thigh (measured to be 10cm above the patella),
Male or female,
14 years or older,
Signed informed consent,
From any ethnic group (may be separated out on data analysis),
Minimum age
14 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Burns to left, right or both thighs
Donor site on other anatomical location other than the thigh,
Psychiatric history documented in the medical chart which could cause variable (self harm) of outcome,
Arterial disease / compromise as documented in the chart,
Have a dermatological condition in the region where the donor site needs to be taken which may affect the result,
Allergy to ultrasound gel,
Refused consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The principal investigator who will determine if a subject is eligible for inclusion in the trial will be unaware of which group the subject will be allocated. Allocation will be concealed via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be randomised via a computerised tablet
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pilot Study - Stand alone baseline only component.
To determine a thigh/buttock/waist measurement (in centimetres) for fitting tubigrip bike pants into the following size ranges; extra small, small, medium, large, extra large.
To determine a pressure range of 18 – 25 mmHg for each Tubigrip Bike pant size, in relation the thigh/waist/buttock measurement.

This study is a baseline only component.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
5/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 256461 0
Charities/Societies/Foundations
Name [1] 256461 0
Private Practice Trust Fund
Country [1] 256461 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
HERSTON QLD
4029
Country
Australia
Secondary sponsor category [1] 255770 0
Individual
Name [1] 255770 0
Professor Michael Muller
Address [1] 255770 0
Division of Surgery
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD
4029
Country [1] 255770 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258513 0
Royal Brisbane and Women's Hospital Human Research Ethics Committe (HREC)
Ethics committee address [1] 258513 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 258513 0
Australia
Date submitted for ethics approval [1] 258513 0
27/10/2009
Approval date [1] 258513 0
03/03/2010
Ethics approval number [1] 258513 0
HREC/09/QRBW/327

Summary
Brief summary
Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24–40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4–6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient’s scar outcomes for donor sites. This study is a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites.
Methods/design
This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months.This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh. No known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimisation.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
Attachments [1] 620 620 0 0
/AnzctrAttachments/335119-HREC ETHICS extension.pdf
Attachments [2] 621 621 0 0
/AnzctrAttachments/335119-UQ Ethics approval 2016.pdf

Contacts
Principal investigator
Name 30798 0
Ms Michelle Donovan
Address 30798 0
Occupational Therapy Department
Royal Brisbane and Women's Hospital
Dr James Mayne Building
Butterfield Street
Herston 4029
Brisbane QLD AUSTRALIA
Country 30798 0
Australia
Phone 30798 0
+61 7 3646 7100
Fax 30798 0
Email 30798 0
michelledonovan@live.com.au
Contact person for public queries
Name 14045 0
Ms Michelle L Donovan
Address 14045 0
Occupational Therapy Department
Royal Brisbane and Women's Hospital
Level 2 Dr James Mayne Building
Butterfield Street
HERSTON QLD 4029
Country 14045 0
Australia
Phone 14045 0
+61 7 3646 7100
Fax 14045 0
+61 7 3646 7495
Email 14045 0
michelledonovan@live.com.au
Contact person for scientific queries
Name 4973 0
Prof Prof Michael Muller
Address 4973 0
Division of Surgery
Royal Brisbane and Women's Hospital
Level 8
Ned Hanlon Building
Butterfield Street
HERSTON QLD 4029
Country 4973 0
Australia
Phone 4973 0
+61 7 3646 1621
Fax 4973 0
+61 7 3646 1314
Email 4973 0
michael.muller@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInterim pressure garment therapy (4-6mmHg) and its effect on donor site healing in burn patients: Study protocol for a randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1329-x
N.B. These documents automatically identified may not have been verified by the study sponsor.