Randomised controlled clinical trial to test the effectiveness of reusable burn gloves vs polythene bags as hand burn treatment

ISRCTN	ISRCTN32223537
DOI	https://doi.org/10.1186/ISRCTN32223537
Secondary identifying numbers	RRCC27R HALL M

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 12/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
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

Mrs Marion Hall
Scientific

York Health Services NHS Trust
Minor Injuries Dept, Selby War Memorial Hospital
Doncaster Road
Selby
YO8 9BX
United Kingdom

Phone	+44 (0)1757 701 314
Email	a@b.c

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled clinical trial to test the effectiveness of reusable burn gloves vs polythene bags as hand burn treatment
Study objectives	Will the clinical effectiveness of this new re-usable burn glove, made with a bacterial barrier, water vapour permeable fabric, be an improvement on the current treatment of polythene bags for partial thickness hand burns? Will the new treatment be cost effective? Partial thickness and superficial hand burns are treated mostly as outpatients. They need frequent redressing until healed, and are therefore costly to the NHS. Treatment of hand burns by bandaging methods in children and by polythene bags in adults, is debilitating, greatly reducing the patients ability to carry out the activities of daily living. Frequent dressing changes are necessary because of the moisture leaked from the burn. In the polythene bag treatment, the skin becomes macerated (soggy), as the bag fills with fluid. The accumulation of fluid in the bag reduces function of the hand during treatment. The semi-permeable and bacterial barrier nature of the fabric glove allows evaporation of the fluid, reducing the maceration, but keeping the burn moist and clean. The gloves are machine washable between use on the same patient and need washing and then sterilising before use on a new patient. The number of times the glove is washed will be recorded. The gloves will be laboratory tested by Lojigma for their effectiveness at the end of the trial. The randomised controlled clinical trial will test the clinical effectiveness in terms of healing time, infection rates, maceration, comfort, pain and function of the hand during treatment. Nurses in the recruiting Accident and Emergency and Minor Injuries Departments will be trained to carry out the trial.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, occupational diseases, poisoning: Burns
Intervention	1. Reusable hand gloves 2. Polythene bags
Intervention type	Other
Primary outcome measure	1. Healing time - measured in days from burn to healed 2. Infection rates - clinical infection treated with antibiotics 3. Bacterial barrier properties of materials - wound swabs to be taken 4. Maceration - clinical judgement made by nurses - confirmed with photographs 5. Comfort and ability to carry out activities of daily living - patient questionnaire 6. Pain - patient questionnaire 7. Movement of hand - measurements made by nurses 8. Assessing the life of the gloves - record number of washes 9. Gloves effectiveness to be tested by Lojigma at end of trial
Secondary outcome measures	Not provided at time of registration
Overall study start date	05/01/1999
Completion date	07/01/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Patients who agree to enter the trial, aged 16 plus who present within 48 hours of the burn in York, Harrogate or Northallerton A&E Departments or Selby Minor Injuries Department 2. They should have with partial thickness hand burns of at least 10% of the hand
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	05/01/1999
Date of final enrolment	07/01/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

York Health Services NHS Trust

Selby
YO8 9BX
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

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

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

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

Editorial Notes

12/12/2019: No publications found. All search options exhausted.