Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC27R HALL M
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Injury, occupational diseases, poisoning: Burns
Intervention
1. Reusable hand gloves
2. Polythene bags
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
05/01/1999
Overall trial end date
07/01/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
05/01/1999
Recruitment end date
07/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
York Health Services NHS Trust
Selby
YO8 9BX
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
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
NHS Executive Northern and Yorkshire (UK)
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