Community RCT of the Effectiveness of Two Compression Bandaging Technologies
NCT ID: NCT00202267
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
426 participants
INTERVENTIONAL
2004-01-31
2008-12-31
Brief Summary
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Detailed Description
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Although rarely recognized as a pressing health care problem, leg ulcers comprise a common, complex, and costly condition. Over 80% of ongoing management of chronic wounds occurs in the community, and leg ulcers are one of the most frequently seen chronic wounds. The cost of leg ulcer care is considerable, being reported in both the UK and France to account for 2% of their total national health budgets. In Canada, the impact is only now being recognized due to the pressure on home care caseloads resulting from hospital downsizing, nursing shortages, and growing numbers of complex health populations. In one Ontario study, the care for fewer than 200 community leg ulcer cases cost in excess of $1.5 million for supplies and nursing visits, which translates to $100s of millions yearly Canada-wide. The impact on the individual is significant--chronic, painful, and often takes years to heal. Two-thirds of individuals with leg ulcers have at least one recurrence, and 45% have a history with the condition dating back 10 years.
State of Knowledge \& Clinical Practice Guidelines:
Over the past decade, evidence from RCT studies and a recent Cochrane systematic review in BMJ demonstrated that venous leg ulcers treated with compression therapy are more likely to heal. Multi-layer high compression systems are more effective than low compression. However, the small number of people in trials comparing different high compression systems meant the review was unable to draw conclusions about their relative merit. Four of these trials have compared 4-layer bandage with short stretch technologies--the most commonly used technologies in Canada. In total, these trials involved only 220 patients, and were thus underpowered. Furthermore, they did not consider factors such as client preference and ease of use, or incorporate an economic evaluation.
Plan of Investigation:
The study will be a multi-centre, pragmatic, randomised trial of two types of compression bandaging technologies, incorporating an economic evaluation.
Research objective: To compare the effectiveness of 2 high compression technologies delivered in the community on ulcer healing, recurrence rates, quality of life, and cost-effectiveness.
Interventions: Four-layer bandage vs. Short-stretch bandage. Sample size: 414 total, 207 in each arm (80% power, " 0.05 to detect 4 week difference in time to heal).
Inclusion Criteria: leg ulcer\>1 cm in any one dimension, minimum duration of 1 week, ABPI\>0.7.
Randomization: will be carried out and stratified by: Clinical Centre (3 Health Regions in Ontario); Margolis' Prognostic Model (ulcer area and duration), Ulcer episode (1st or recurrent ulcer).
Analysis: Primary outcome: time-to-healing of the reference ulcer.
Secondary outcomes: quality of life \& expenditures for treatment. Durability of healing will be assessed-follow-up for up to 52 weeks post-healing to determine recurrence rates associated with both technologies.
Summary:
There is consensus internationally in recommending the application of graduated multi-layer compression. High compression is more effective than low compression; however, there is no clear evidence as to which high compression technology is more effective.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Clients randomized to short-stretch bandaging application
Short-stretch Bandage (Non-elastomeric)
These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.
2
Clients randomized to four-layer bandaging application
Four-layer Bandage (Elastomeric)
Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.
Interventions
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Four-layer Bandage (Elastomeric)
Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.
Short-stretch Bandage (Non-elastomeric)
These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* leg ulcer equal to or larger than 0.7 cm in any one dimension
* ulcer a minimum duration of 1 week
* ankle brachial pressure index equal to or greater than 0.80
* participant can provide written consent
* participant can communicate in English, or translation available
* participant 18 years or over
Exclusion Criteria
* participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
* previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
* symptoms of cognitive impairment noted
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Queen's University
OTHER
Responsible Party
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Dr. Margaret Harrison
Principal Investigator
Principal Investigators
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Margaret B Harrison, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Ian D Graham, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa (co-investigator)
Elizabeth A Nelson, PhD
Role: STUDY_DIRECTOR
University of Leeds, UK (co-investigator)
Karen Lorimer, MNSc
Role: STUDY_DIRECTOR
Victorian Order of Nurses (co-investigator)
Connie Harris, MNSc
Role: STUDY_DIRECTOR
ET NOW (co-investigator)
Elizabeth VanDenKerkhof, PhD
Role: STUDY_DIRECTOR
School of Nursing, Queen's University
Locations
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Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada
Nursing Practice Solutions
Fort Erie, Ontario, Canada
VON Hamilton Branch
Hamilton, Ontario, Canada
Saint Elizabeth Health Care
Kingston, Ontario, Canada
Kingston Chronic Wound Clinic
Kingston, Ontario, Canada
ParaMed Health Services
Kingston, Ontario, Canada
ET Now
Kitchener, Ontario, Canada
Carefor
Ottawa, Ontario, Canada
ParaMed Health Services
Ottawa, Ontario, Canada
St. Joseph's Care Group
Thunder Bay, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
ParaMed Home Health Care
Toronto, Ontario, Canada
Comcare Health
Toronto, Ontario, Canada
Ostomy and Wound Care Centre
Regina, Saskatchewan, Canada
Saskatoon Health Region Home Care
Saskatoon, Saskatchewan, Canada
Countries
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References
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Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
Pham B, Harrison MB, Chen MH, Carley ME; Canadian Bandaging Trial Group. Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial. BMC Health Serv Res. 2012 Oct 2;12:346. doi: 10.1186/1472-6963-12-346.
Harrison MB, Vandenkerkhof EG, Hopman WM, Graham ID, Carley ME, Nelson EA; Canadian Bandaging Trial Group. The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies. BMC Nurs. 2011 Oct 13;10:20. doi: 10.1186/1472-6955-10-20.
Related Links
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Canadian Institutes of Health Research
Other Identifiers
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394622
Identifier Type: -
Identifier Source: secondary_id
MCT 63175
Identifier Type: -
Identifier Source: org_study_id