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The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies.


ABSTRACT: BACKGROUND: OBJECTIVE:To determine the relative effectiveness of evidence-informed practice using two high compression systems: four-layer (4LB) and short-stretch bandaging (SSB) in community care of venous leg ulcers. DESIGN AND SETTING:Pragmatic, multi-centre, parallel-group, open-label, randomized controlled trial conducted in 10 centres. Cognitively intact adults (?18 years) referred for community care (home or clinic) with a venous ulceration measuring ?0.7cm and present for ?1 week, with an ankle brachial pressure index (ABPI) ?0.8, without medication-controlled Diabetes Mellitus or a previous failure to improve with either system, were eligible to participate. METHODS:Consenting individuals were randomly allocated (computer-generated blocked randomization schedule) to receive either 4LB or SSB following an evidence-informed protocol. Primary endpoint: time-to- healing of the reference ulcer. SECONDARY OUTCOMES:recurrence rates, health-related quality of life (HRQL), pain, and expenditures. RESULTS:424 individuals were randomized (4LB n = 215; SSB n = 209) and followed until their reference ulcer was healed (or maximum 30 months). An intent-to-treat analysis was conducted on all participants. Median time to ulcer healing in the 4LB group was 62 days [95% confidence interval (CI) 51 to 73], compared with 77 days (95% CI 63 to 91) in the SSB group. The unadjusted Kaplan-Meier curves revealed the difference in the distribution of cumulative healing times was not significantly different between group (log rank ?2 = 0.001, P = 0.98) nor ulcers recurrence (4LB, 10.1%; SSB, 13.3%; p = 0.345). Multivariable Cox Proportional Hazard Modeling also showed no significant between-bandage differences in healing time after controlling for significant covariates (p = 0.77). At 3-months post-baseline there were no differences in pain (no pain: 4LB, 22.7%; SSB, 26.7%; p = 0.335), or HRQL (SF-12 Mental Component Score: 4LB, 55.1; SSB, 55.8; p = 0.615; SF-12 Physical Component Score: 4LB, 39.0; SSB, 39.6; p = 0.675). The most common adverse events experienced by both groups included infection, skin breakdown and ulcer deterioration. CONCLUSIONS:The Canadian Bandaging Trial revealed that in the practice context of trained RNs using an evidence-informed protocol, the choice of bandage system (4LB and SSB) does not materially affect healing times, recurrence rates, HRQL, or pain. From a community practice perspective, this is positive news for patient-centred care allowing individual/family and practitioner choice in selecting compression technologies based on circumstances and context. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00202267.

SUBMITTER: Harrison MB 

PROVIDER: S-EPMC3214126 | BioStudies | 2011-01-01

REPOSITORIES: biostudies

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