Four layer bandage compared with short stretch bandage for venous leg ulcers: systematic review and meta-analysis of randomised controlled trials with data from individual patients

Abstract

Objective To compare the effectiveness of two types of compression treatment (four layer bandage and short stretch bandage) in people with venous leg ulceration.Design Systematic review and meta-analysis of patient level data. Data sources Electronic databases (the Cochrane CentralRegister of Controlled Trials, the Cochrane Wounds Group Specialised Register, Medline, Embase, CINAHL, and National Research Register) and reference lists of retrieved articles searched to identify relevant trials and primary investigators. Primary investigators of eligible trials were invited to contribute raw data for re-analysis.Review methods Randomised controlled trials of four layer bandage compared with short stretch bandage in people with venous leg ulceration were eligible for inclusion. The primary outcome for the meta-analysis was time to healing. Cox proportional hazards models were run to compare the methods in terms of time to healing with adjustment for independent predictors of healing. Secondary outcomes included incidence and number of adverse events per patient.Results Seven eligible trials were identified (887 patients), and patient level data were retrieved for five (797 patients, 90% of known randomised patients). The four layer bandage was associated with significantly shorter time to healing: hazard ratio (95% confidence interval) from multifactorial model based on five trials was 1.31 (1.09 to 1.58), P=0.005. Larger ulcer area at baseline, more chronic ulceration, and previous ulceration were all independent predictors of delayed healing. Data from two trials showed no evidence of a difference in adverse event profiles between the two bandage types.Conclusions Venous leg ulcers in patients treated with four layer bandages heal faster, on average, than those of people treated with the short stretch bandage. Benefits were consistent across patients with differing prognostic profiles. INTRODUCTIONVenous leg ulcers are a common and recurring chronic wound caused by damage to the veins and consequent high venous pressure.1 The estimated lifetime prevalence for leg ulceration in developed countries is 1% and the point prevalence is 0.1-0.2%. Prevalence increases with age and is higher among women.2 The UK Healthcare Commission has estimated that currently leg ulcer care costs the NHS £300-600m (€330-661m, $447-895m) a year.3 A substantial proportion of the costs is attributable to nursing time.4 5 These ulcers are also associated with increased costs and reduced health related quality of life for patients.

A Systematic Review and Meta-analysis of Exercise Intervention for the Treatment of Calf Muscle Pump Impairment in Individuals with Chronic Venous Insufficiency

“…51 A meta-analysis of RCTs with pooling of individual patient data from five trials comparing 4LB with short stretch bandage found that the 4LB was associated with a significantly shorter time to healing. 53 The VenUS study, found that 4LB was less expensive than non-cohesive SSB which required more re-applications and changes of dressings. However, the SSB could have been reused or replaced by cohesive SSB which can stay in place for up to a week and the cost of nurse training in 4LB was not considered.…”

“…In a Cochrane review, most of the trials comparing single layer systems with multicomponent systems were small and underpowered. 53 A single large RCT (n=245) suggested a benefit for four layer bandage (4LB) when compared with elastic adhesive single component compression. 54 One trial compared two components with four components and found a statistically significant difference in frequency of complete healing in favour of the 4LB at six months.…”

Wounds research for patient benefit: a 5-year programme of research

“…Many of the important data requirements for venous leg ulcer research have already been established from prognostic research, experience with large RCTs and an existing example of IPD meta-analysis in wound management. 18,19,187,225,226 For example, larger ulcer area and longer ulcer duration at the outset of treatment are known to be independent and significant predictors of delayed healing. 225,226 In terms of outcome assessment, time to healing is considered as much more informative than frequency of complete healing at fixed time points or intermediate healing measures because it provides information not only on whether or not healing occurs but also on how long it takes to occur.…”

“…In this case, an earlier Cochrane review had not shown a difference in healing between the two bandages when trial-level data were pooled, 184 whereas a subsequent IPD meta-analysis of the same comparison, involving estimation from an adjusted Cox proportional hazards model, showed that, on average, patients healed faster with the four-layer bandage. 187 The main issue with undertaking IPD meta-analysis is that the success of the endeavour is contingent on the review team being able to access the original data for each eligible primary study, although IPD meta-analysis may still be beneficial even if data can be obtained for only a subset of eligible studies. Access to the original patient-level data may not always be straightforward; for example, data may no longer be available for older studies.…”

Provisional Matrix Deposition in Hemostasis and Venous Insufficiency: Tissue Preconditioning for Nonhealing Venous Ulcers

“…5a, b). 126 O'Brien et al obtained a 54% healing rate at 3 months in patients using a four layer compression system, in comparison to 34% healed in a control group receiving 'usual care', where only 5 of 100 participants received some type of compression. 127 In a standing individual, the venous pressure, which equals the weight of the blood column between the foot and right atrium, is about 80-100 mm Hg.…”