title: 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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 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.
  
  
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00202267.
authors: School of Nursing, Queen's University, Kingston, Ontario, Canada. margaret.b.harrison@queensu.ca.
authors: Margaret B
authors: MB
authors: Harrison
authors: Elizabeth G
authors: EG
authors: Vandenkerkhof
authors: Wilma M
authors: WM
authors: Hopman
authors: Ian D
authors: ID
authors: Graham
authors: Meg E
authors: ME
authors: Carley
authors: E Andrea
authors: EA
authors: Nelson