The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologiesReport as inadecuate

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BMC Nursing

, 10:20

First Online: 13 October 2011Received: 24 June 2011Accepted: 13 October 2011


BackgroundObjective: 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.

MethodsConsenting 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.

Results424 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 χ2 = 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.

ConclusionsThe 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 Identifier: NCT00202267

Electronic supplementary materialThe online version of this article doi:10.1186-1472-6955-10-20 contains supplementary material, which is available to authorized users.

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Author: Margaret B Harrison - Elizabeth G VanDenKerkhof - Wilma M Hopman - Ian D Graham - Meg E Carley - E Andrea Nelson - the


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