Contact information
Type
Scientific
Primary contact
Dr Nicky Cullum
ORCID ID
Contact details
Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321343
nac2@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 96/12/26
Study information
Scientific title
Acronym
Study hypothesis
Compression bandaging is the mainstay of venous leg ulcer treatment, however the optimal bandage regimen is unclear and there are large variations in practice. The 4 layer bandage (4LB) is used widely in the UK but is discarded after a single use and is relatively expensive. The short-stretch bandage (SSB) id the standard bandage in Europe, and is reusable. A recent systematic review demonstrated the paucity of RCTs in this area, and those that exist are of poor quality. The review also showed that multilayer bandaging is more effective than single layer; high compression systems such as the 4LB and SSB are more effective than low compression systems; however the two trials that have compared SSB and 4LB were vastly underpowered and did not incorporate an economic analysis. This study proposes to compare the 4LB and SSB systems in a two-arm pragmatic RCT involving 400 patients with venous ulcers. Patients will be followed up until healing or for a maximum period of 30 months.
Substantial benefits to the NHS and patients will occur if the trial demonstrated one of the bandages is superior to the other; substantial resource savings would occur in bandage expenditure if it were shown that the SSB was of at least equivalent effectiveness to the 4LB.
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
Condition
Varicose veins/ulcers
Intervention
1. 4 layer bandage
2. Short stretch bandage
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Proportion of ulcers completely healed; healing rates; costs; quality of life; recurrence rates at 12 months.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1998
Overall trial end date
31/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with leg ulcers
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1998
Recruitment end date
31/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15382102
Publication citations
-
Results
Nelson EA, Iglesias CP, Cullum N, Torgerson DJ, , Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers (VenUS I)., Br J Surg, 2004, 91, 10, 1292-1299, doi: 10.1002/bjs.4754.