Is the Short-stretch bandage or the 4-layer bandage more effective in treating leg ulcers?
| ISRCTN | ISRCTN37782978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37782978 |
| ClinicalTrials.gov number | NCT00202267 |
| Secondary identifying numbers | MCT-63175 |
- Submission date
- 01/03/2006
- Registration date
- 01/03/2006
- Last edited
- 22/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Margaret B. Harrison
Scientific
Scientific
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
| Phone | +1 613 533 6000 ext 74760 |
|---|---|
| Margaret.B.Harrison@queensu.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Community randomised controlled trial on the effectiveness of two compression bandaging technologies |
| Study acronym | CBT (Canadian Bandaging Trial) |
| Study objectives | 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(s) | Research Ethics Board of Queen's University Health Sciences and Affiliated Teaching Hospitals, Kingston, Ontario (Canada) approved on the 8th July 2003. Renewed annually. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 11/01/2003 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Added as of 08/05/2009: 424 (previously 414) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/01/2003 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
Professor, School of Nursing
Kingston
K7L 3N6
Canada
K7L 3N6
Canada
Sponsor information
Queen's University (Canada)
University/education
University/education
207 Stuart St
Kingston
K7L 3N6
Canada
| Website | http://www.queensu.ca/ |
|---|---|
"ROR" |
https://ror.org/02y72wh86 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63175)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/10/2012 | Yes | No |
