ANZCTR - Registration

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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]

'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

Compression Garment Therapy

Condition category

Condition code

Injuries and Accidents

Burns

Skin

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]

Treatment: Devices

Comparator / control treatment

The control group will not have Elastic bikepants or equivalent.

Control group

Active

Outcomes

Primary outcome [1]

Mean donor scar skin thickness (Dermascan C Ultrasound )

Timepoint [1]

Measured at day 5, then every fortnight for a period of 3 months.

Primary outcome [2]

Reduction of time to epitheleisation (Dermascan C ultrasound)

Timepoint [2]

Measured at day 5, then every fortnight for a period of 3 months.

Secondary outcome [1]

pressure in the elastic bikepants of >/= 15mmHg (Pico Press Pressure Sensor)

Timepoint [1]

Measured at day 5, then every fortnight after for a period of 3 months.

Secondary outcome [2]

Improvement of overall scar appearance (Patient Observer Scar Assessment Scale (POSAS))

Timepoint [2]

Day 5, then every fortnight for a period fo 3 months

Secondary outcome [3]

Reduction in self reported pain level
(Patient Observer Scar Assessment Scale (POSAS))s

Timepoint [3]

Day 5, then every fortnight for a period fo 3 months

Secondary outcome [4]

Skin type (Fitzpatricks Skin Phototype)

Timepoint [4]

Initial assessment day 5 post op.

Secondary outcome [5]

Erythema (redness) of skin (Colourmeter)

Timepoint [5]

Day 5, then every fortnight for a period fo 3 months

Secondary outcome [6]

normal skin comparison on same leg, anatomically close to donor site.

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Private Practice Trust Fund

Address [1]

The Private Practice Trust Fund
Royal Brisbane and Women's Hospital
Corporate Office, Lower Ground Floor
Dr James Mayne Building
Butterfield Street Herston QLD 4029

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Brisbane and Women's Hospital

Address

Butterfield Street
HERSTON QLD
4029

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Michael Muller

Address [1]

Division of Surgery
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD
4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital Human Research Ethics Committe (HREC)

Ethics committee address [1]

Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street 
Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/10/2009

Approval date [1]

03/03/2010

Ethics approval number [1]

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]

/AnzctrAttachments/335119-HREC ETHICS extension.pdf

Attachments [2]

/AnzctrAttachments/335119-UQ Ethics approval 2016.pdf

Contacts

Principal investigator

Name

Ms Michelle Donovan

Address

Occupational Therapy Department
Royal Brisbane and Women's Hospital
Dr James Mayne Building
Butterfield Street
Herston 4029
Brisbane QLD AUSTRALIA

Country

Australia

Phone

+61 7 3646 7100

Fax

michelledonovan@live.com.au

Contact person for public queries

Name

Michelle L Donovan

Address

Occupational Therapy Department
Royal Brisbane and Women's Hospital
Level 2 Dr James Mayne Building
Butterfield Street
HERSTON QLD 4029

Country

Australia

Phone

+61 7 3646 7100

Fax

+61 7 3646 7495

michelledonovan@live.com.au

Contact person for scientific queries

Name

Prof Michael Muller

Address

Division of Surgery
Royal Brisbane and Women's Hospital
Level 8
Ned Hanlon Building
Butterfield Street
HERSTON QLD 4029

Country

Australia

Phone

+61 7 3646 1621

Fax

+61 7 3646 1314

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

Source	Title	Year of Publication	DOI
Embase	Interim pressure garment therapy (4-6mmHg) and its effect on donor site healing in burn patients: Study protocol for a randomised controlled trial.	2016	https://dx.doi.org/10.1186/s13063-016-1329-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically