ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000105741

Ethics application status

Approved

Date submitted

25/01/2013

Date registered

25/01/2013

Date last updated

21/03/2022

Date data sharing statement initially provided

21/03/2022

Date results provided

21/03/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

A study to compare the effect of three burns dressings on burns in children

Scientific title

The effect of three different burns dressings on time to re-epithelialisation of partial thickness burns in children: a randomised control trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Paediatric partial thickness burns

Condition category

Condition code

Injuries and Accidents

Burns

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A comparison of three dressings currently being used. Group 1: Burn wound will be dressed with Acticoat (a silver containing dressing without a silicone skin interface). Participants will have their dressing changed twice weekly until the wound re-epithelialises or grafting is required; Group 2: Burn wound will be dressed with Acticoat and Mepitel (a silicone coated nylon grid dressing) Participants will have their dressing changed twice weekly until the wound re-epithelialises or grafting occurs; Group 3: Burn wound will be dressed with Mepilex Ag (soft foam, silver containing dressing with safe-tac technology). Participants will have their dressing changed twice weekly until the wound re-epithelialises or grafting occurs.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

There is no placebo group in this study as it would be unethical not to dress burn wounds or to use an older, inferior dressing. Therefore the Acticoat, Acticoat and Mepitel and MepilexAg groups will be compared to each other as active control groups.

Control group

Active

Outcomes

Primary outcome [1]

Time (days) to re-epithelialisation of burn wound will be measured using two methods. 1: The VisitrakTM (Smith and Nephew) digital device will be used (by an unblinded assessor) to calculate wound area and assess wound re-epithelialisation; 2: Digital photography (3D LifeViz camera software, Quantificare) will be used by a blinded assessor (burns surgeon not involved in patient's care) to measure the area of re-epithelialisation. Both measurement methods to be undertaken at each dressing change (every 3 days).

Timepoint [1]

Every 3 days (each dressing change) after intervention commencement until wound is re-epithelialised.

Primary outcome [2]

Impact of dressings on pain and anxiety during changes: Child self report using the Revised Faces scale (FACES); Caregiver-report (or self-report of child 8 years or older) of child's level of pain using a 0-10 visual analogue scale. Pulse rate, respiratory rate and analgesia requirements also to be recorded. All measurements to be taken by a blinded assessor at each dressing change (every 3 days).

Timepoint [2]

Every 3 days (each dressing change) after intervention commencement until wound is re-epithelialised.

Secondary outcome [1]

Scar assessment using the Patient and Observer Scar Assessment Scale v2 (POSAS); digital photography; and ultrasound to determine scar thickness and ratio of scar thickness to normal adjacent skin. Measures taken by blinded assessor from point of healing.

Timepoint [1]

Point of healing, 3 and 6 months post-healing.

Secondary outcome [2]

Effect of wound dressing on physical functioning using parent/caregiver and child (>8years) self report on a visual analogue scale.

Timepoint [2]

Every 3 days (each dressing change).

Secondary outcome [3]

Grafting of wound required (yes/no)

Timepoint [3]

Intervention commencement

Secondary outcome [4]

Cost effectiveness of each dressings trialled (number of nurses required at each dressing change, time taken for procedure, amount and type of dressing used, grafting requirements, scar management costs (clinic attendance and use of resources)

Timepoint [4]

Every 3 days (each dressing change) and at point of healing, 3 and 6 months post-healing

Secondary outcome [5]

Qualitative data from nursing staff on each dressing combination (e.g. ease of use).

Timepoint [5]

Conclusion of trial

Eligibility

Key inclusion criteria

Children with acute superficial partial to deep partial thickness burn injuries <10% TBSA (total body surface area), presenting to Royal Children's Hospital, Brisbane within 72hours of injury.

Minimum age

No limit

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Superficial and full thickness burns
Burns >10% TBSA
Known sensitivity to silver
Chemical and friction burns
Non-English speaking
Cognitive impairment

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)

Treating physicians/nursing staff of all children meeting the inclusion/exclusion criteria presenting the to the Royal Children's Hospital, Brisbane will determine eligibility for enrolement in the study. An investigator aligned with the study will discuss the study with parents/caregivers/child and seek informed consent. Participants will then be randomised into one of the three treatment groups. Allocated concealment will be undertaken by the use of sealed, opaque, idential and serially numbered envelopes prepared by an independent party.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomisation.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Demographic and baseline outcome measures will be compared.
An ANOVA or suitable non-parametric test will compare outcome measures between groups.
Analysis will be by intention to treat and per protocol.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

18/03/2013

Actual

18/03/2013

Date of last participant enrolment

Anticipated

Actual

12/01/2014

Date of last data collection

Anticipated

Actual

11/07/2014

Sample size

Target

100

Accrual to date

Final

103

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Children's Hospital - Herston

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Molnlycke Healthcare Australia

Address [1]

Suite 1.01
10 Tilley Lane
Frenchs Forest NSW 2086

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Sir Fred Schonell Dr
St Lucia QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Services Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

EC00175

Ethics committee name [2]

The University of Queensland Medical Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

EC00179

Summary

Brief summary

At the Royal Children's Hospital in Brisbane the standard of care in burns dressings for small to medium partial thickness burns has changed over the years. Currently, silver containing dressings are used to prevent infection and promote healing.  However despite the large number of burns dressings available on the market, very few high level trials have been conducted in children or adults. This study aims to determine the effect of various silver and silicone containing burns dressings for the treatment of partial thickness burns in children. 

The study hypothesises that:
1. Rate of healing, need for grafting and subsequent scarring from a burn wound is partly determined by the choice of dressing used.
2. The choice of dressings used can partly assist with pain and anxiety strategies during dressing change procedures; and impacts on a child's comfort and engagement in activities.
3. The dressing which best fulfils the above qualities will also be the most cost effective.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Roy Kimble

Address

Queensland Children's Medical Research Insitute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 3636 8111

Fax

royk@uq.edu.au

Contact person for public queries

Name

Roy Kimble

Address

Queensland Children's Medical Research Insitute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 3636 8111

Fax

royk@uq.edu.au

Contact person for scientific queries

Name

Roy Kimble

Address

Queensland Children's Medical Research Institute
Level 4 Foundation Bldg
Royal Children's Hospital
Herston Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 3636 8111

Fax

royk@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	3D photography is a reliable burn wound area assessment tool compared to digital planimetry in very young children.	2015	https://dx.doi.org/10.1016/j.burns.2015.01.020
Embase	Scar outcome of children with partial thickness burns: A 3 and 6 month follow up.	2016	https://dx.doi.org/10.1016/j.burns.2015.06.019
Embase	Cost-effectiveness of silver dressings for paediatric partial thickness burns: An economic evaluation from a randomized controlled trial.	2017	https://dx.doi.org/10.1016/j.burns.2016.09.018

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

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Documents added automatically