Acceptability and effectiveness of Burnshield dressing in the early treatment of uncomplicated partial thickness burns in the A&E Department

ISRCTN	ISRCTN31271577
DOI	https://doi.org/10.1186/ISRCTN31271577
Secondary identifying numbers	N0226187455

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Nick Payne
Scientific

University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 0161 291 6048
Email	nick.payne@uhsm.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To investigate the effectiveness of a Burnshield dressing as first treatment in patients with uncomplicated partial thickness burns in reducing infection and pain as compared with standard treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Burns
Intervention	1. Burnshield 2. Atrauman (standard treatment) for 24 hours After 24 hours all patients will receive Atrauman dressing. Added September 2008: trial was stopped due to lack of resources.
Intervention type	Other
Primary outcome measure	Pain scoring (Wong and Baker scale) and analgesia usage between Burnshield and Atrauman groups.
Secondary outcome measures	No secondary outcome measures
Overall study start date	03/01/2007
Completion date	03/08/2007
Reason abandoned (if study stopped)	Lack of resources

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Sex	Not Specified
Target number of participants	242 participants; 121 (50%) in control group
Key inclusion criteria	1. Age over 1 year 2. Partial thickness burn under 10% of body surface area 3. Injury less than 2 hours old 4. Patient/parent consents
Key exclusion criteria	1. Age <1 year 2. Pregnancy 3. First aid other than cold water, soaked dressings or cling film 4. Requiring fluid resuscitation or referral to plastics 5. Requiring admission for other injury 6. Systemic disease likely to affect healing (DM, PVD)
Date of first enrolment	03/01/2007
Date of final enrolment	03/08/2007

University Hospital of South Manchester NHS Foundation Trust

Manchester
M23 9LT
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

University Hospital of South Manchester NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan