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 |
| Protocol serial number | N0226187455 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | University Hospital of South Manchester NHS Foundation Trust (UK), NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 05/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Mr Nick Payne
Scientific
Scientific
University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 0161 291 6048 |
|---|---|
| nick.payne@uhsm.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Pain scoring (Wong and Baker scale) and analgesia usage between Burnshield and Atrauman groups. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 03/08/2007 |
| Reason abandoned (if study stopped) | Lack of resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Sex | Not Specified |
| Target sample size at registration | 242 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospital of South Manchester NHS Foundation Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
