Contact information
Type
Scientific
Primary contact
Mr Nick Payne
ORCID ID
Contact details
University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 0161 291 6048
nick.payne@uhsm.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226187455
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Pain scoring (Wong and Baker scale) and analgesia usage between Burnshield and Atrauman groups.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
03/01/2007
Overall trial end date
03/08/2007
Reason abandoned
Lack of resources
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
242 participants; 121 (50%) in control group
Participant 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)
Recruitment start date
03/01/2007
Recruitment end date
03/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital of South Manchester NHS Foundation Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary