Background

Chronic wounds are managed almost entirely by community nurses. Almost all individuals with leg ulcers report acute pain usually related to dressing change. Little is known about pain after healing. The purpose of this study was to explore the course of pain from baseline to time of healing of leg ulcers (venous or mixed etiology). In order to understand this phenomenon and develop implications for nursing practice, objectives included: 1) Measure incidence and prevalence of pain at baseline and healing; 2) Describe characteristics associated with leg ulcer pain at baseline; 3) Identify predictors of leg ulcer pain at healing.

Methods

Data were from one randomized controlled trial (2004-2008) of 424 individuals with leg ulcers in the community receiving evidence-informed nursing management. The primary outcome was pain at the time of healing. Predictive factors included demographic, circumstance of living, clinical and ulcer characteristics. Multivariable logistic regression identified the subset of predictors of pain at healing. Odds ratios (OR) and 95% confidence intervals (CI) are reported.

Results

Eighty-two percent of participants reported pain at baseline and 32% at healing. Five percent with no pain at baseline reported pain at healing. Thirty-seven percent reported moderate to severe pain at baseline and 11% at healing. Twenty percent of all those who healed reported pain interfered with work moderately to extremely at time of healing. Being female (OR=1.64, 95% CI 1.00, 2.68, p=0.05), use of short-stretch vs. four-layer bandages (OR=1.73, 95% CI 1.06, 2.82, p=0.03), lower SF-12 PCS (OR=0.97, 95% CI 0.94, 0.99, p=0.02) and MCS (OR=0.98, 95% CI 0.95-1.00, p=0.04) scores, use of non-steroidal anti-inflammatory drugs (OR=2.28, 95% CI 1.06, 4.88, p=0.03), and tender pain (OR=2.17, 95% CI 1.29, 3.66, p=<0.01) were associated with pain at time of healing.

Conclusions

Pain is an issue on admission for chronic wounds and at healing, yet 58% with moderate to severe pain on admission were not taking pain medication(s). Future studies should examine the role of pain at healing and at subsequent ulcer recurrence. Mobility and other factors that may contribute to pain at time of healing should also be assessed. Community nurses are encouraged to consider pain when planning care on admission and also after wound healing, when most patients are discharged from care.

Trial registration

ClinicalTrials.gov, NCT00202267

Background

Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: ‘four-layer bandage’ (4LB) and ‘short-stretch bandage’ (SSB).

Methods

We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215) and SSB (n = 209) for community care of venous leg ulcers. We estimated costs (in 2009–2010 Canadian dollars) from the societal perspective and used a time horizon corresponding to each trial participant’s first year.

Results

Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [−32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [−0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used); or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%.

Conclusions

Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money.

Trial registration

ClinicalTrials.gov Identifier: NCT00202267

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 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.

Trial registration

clinicaltrials.gov Identifier: NCT00202267