Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Marion Hall

ORCID ID

Contact details

York Health Services NHS Trust
Minor Injuries Dept
Selby War Memorial Hospital
Doncaster Road
Selby
YO8 9BX
United Kingdom
+44 (0)1757 701 314

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes