Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes