Contact information
Type
Scientific
Primary contact
Dr Margaret B. Harrison
ORCID ID
Contact details
Professor
School of Nursing
Director
Joanna Briggs Collaboration
Senior Scientist
Practice and Research in Nursing Group
Queen's University
90 Barrie Street
Kingston
K7L 3N6
Canada
+1 613 533 6000 ext 74760
Margaret.B.Harrison@queensu.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00202267
Protocol/serial number
MCT-63175
Study information
Scientific title
Community randomised controlled trial on the effectiveness of two compression bandaging technologies
Acronym
CBT (Canadian Bandaging Trial)
Study hypothesis
To determine whether there is a 4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system; the time to complete healing of the reference ulcer (one year randomisation, follow-up to 30 months).
As of 08/05/2009 this record was updated to include changes to the protocol. All changes can be found under the relevant field. At this time the anticipated end date of this trial was also updated; the initial end date at the time of registration was 30/09/2007.
Ethics approval
Research Ethics Board of Queen's University Health Sciences and Affiliated Teaching Hospitals, Kingston, Ontario (Canada) approved on the 8th July 2003. Renewed annually.
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
Venous ulcer (leg)
Intervention
Four-layer bandage versus short-stretch bandage for four weeks with a follow-up until 12 months after healing in some cases until a maximum of 30 months
Trial details received: 12 Sept 2005.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time-to-healing of the reference ulcer (comparison of four-layer and short-stretch over 4 week period)
Secondary outcome measures
Current information as of 08/05/2009:
Over a one-year follow-up:
1. Rate of reduction in ulcer area for a maximum of 30 months
2. Proportion of ulcers healed at 12 and 24 weeks in each arm
2. Durability of Healing: Recurrence rates during 12 months after healing
3. Quality of life (McGill Short Form Pain Questionnaire; SF-12; EuroQol on five dimensions-Mobility, self care, usual activities, pain/discomfort and anxiety depression) at 12 months after healing
4. Expenditures for treatment
Initial information at time of registration
Over a one-year follow-up:
1. Rate of reduction in ulcer area for a maximum of 30 months
2. Recurrence rates during 12 months after healing
3. Quality of life (McGill Short Form Pain Questionnaire; SF-12; self-administered survey) at 12 months after healing
4. Expenditures for treatment
Overall trial start date
11/01/2003
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Current information as of 08/05/2009:
1. 18 years or older, either sex, ability to communicate in English
2. Could provide written informed consent
3. Had an ulcer of a minimum duration of 1 week
4. Had a clinical presentation of venous insufficiency
5. Had a leg ulcer that measured 0.7 cm in any one dimension
6. Ankle brachial pressure index greater than or equal to 0.8
Initial information at time of registration
1. 18 years or older, either sex, ability to communicate in English
2. Leg ulcer greater than 1 cm in any one dimension, minimum duration of 1 week, Ankle Brachial Pressure Index (ABPI) greater than 0.7
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added as of 08/05/2009: 424 (previously 414)
Participant exclusion criteria
Current information as of 08/05/2009:
1. Had diabetes (taking insulin or an oral hypoglycaemic)
2. Had failed to improve over a 3-month period after being treated with either bandaging systems prior to the trial
3. Had been a previous study patient
4. Were cognitively impaired
Initial information at time of registration
1. Diagnosis of diabetes mellitus
2. Participants who failed to improve over a 3-month period after being treated previously with either of the trial treatments
3. Previous trial patients
4. Cognitive impairment
Recruitment start date
11/01/2003
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Professor, School of Nursing
Kingston
K7L 3N6
Canada
Sponsor information
Organisation
Queen's University (Canada)
Sponsor details
207 Stuart St
Kingston
K7L 3N6
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63175)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23031428
Publication citations
-
Results
Pham B, Harrison MB, Chen MH, Carley ME, , Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial., BMC Health Serv Res, 2012, 12, 346, doi: 10.1186/1472-6963-12-346.