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4 layer bandages were better than 1 layer bandages, and pentoxifylline may be better than placebo for venous leg ulcers
  1. Julie Betts, RN, NP, MN
  1. Waikato District Health Board, Hamilton, New Zealand

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 Q In patients with venous leg ulcers, which drug, bandage, and dressing options are most effective for healing?

    METHODS

    Embedded ImageDesign:

    2×2×2 factorial randomised controlled trial.

    Embedded ImageAllocation:

    concealed.

    Embedded ImageBlinding:

    partially blinded (patients and healthcare providers were blinded to the drug intervention only).

    Embedded ImageFollow up period:

    24 weeks.

    Embedded ImageSetting:

    2 centres in Scotland, UK.

    Embedded ImagePatients:

    245 patients >18 years of age (mean age 70 y, 67% women) with clinical signs of venous disease and a venous leg ulcer ⩾1 cm in length and ⩾8 weeks in duration. Exclusion criteria included important arterial disease, diabetes, and infected or gangrenous ulcers.

    Embedded ImageInterventions:

    pentoxifylline, sustained release 400 mg 3 times daily, (n = 121) or placebo (n = 124); 4 layer bandage (n = 117) or adhesive 1 layer bandage (n = 128); and hydrocolloid dressing (n = 127) or knitted viscose dressing (n = 118).

    Embedded ImageOutcomes:

    time to complete healing, proportion of patients with healed ulcers, withdrawals, and adverse events.

    Embedded ImagePatient follow up:

    100% (intention to treat analysis).

    MAIN RESULTS

    Pentoxifylline decreased time to healing more than placebo (adjusted analysis only), and 4 layer bandages decreased time to healing more than 1 layer bandages; hydrocolloid and knitted viscose dressings did not differ (table). The proportion of patients with healed ulcers at 24 weeks differed only for the comparison of 4 layer and 1 layer bandages (table). Pentoxifylline and placebo did not differ for adverse events or withdrawals. The group with the combination of knitted viscose dressing and 1 layer bandage had a higher withdrawal rate (38%) than the groups with the other 3 combinations (13–18%).

    Pentoxifylline v placebo, 4 layer v 1 layer bandages, and hydrocolloid v knitted viscose dressings for venous leg ulcers at 24 weeks*

    CONCLUSIONS

    4 layer bandages were better than 1 layer bandages, and pentoxifylline was better than placebo for venous leg ulcer healing. Hydrocolloid dressings did not differ from knitted viscose dressings.

    Commentary

    Uncertainty still exists as to the most effective method of compression therapy to heal venous leg ulcers. The study by Nelson et al helps to clarify this issue and evaluates the benefits of 2 dressing types and the use of pentoxifylline. Some results of this study were published previously,1 but this is the first time that all of the results have been presented. Nelson et al found multilayer compression to be more effective than single layer, whereas hydrocolloid dressings and knitted viscose dressings did not differ. These findings are congruent with those of the VenUS I trial and a recent systematic review.2,3

    The results for pentoxifylline were more complicated. The unadjusted analysis was borderline non-significant, whereas the adjusted analysis was borderline significant. Which to believe? Fortunately, the study by Nelson et al has been incorporated into a meta-analysis that included 4 other similar trials.4 That review found that pentoxifylline was an effective adjunct to compression, and an economic analysis showed that use of pentoxifylline could save £153 per healed patient.5 Some results have suggested pentoxifylline might be more effective when used for hard-to-heal ulcers. A prognostic index could be used to identify patients with ulcers most likely to benefit from early treatment.

    The clinical implication of the trial by Nelson et al, when considered alongside other evidence, is that it matters little which dressings are used on ulcers. Treatments must address the underlying cause of the ulcer. Compression and adjuvant pentoxifylline are just such treatments.

    View Abstract

    Footnotes

    • For correspondence: Dr E A Nelson, University of Leeds, Leeds, UK. e.a.nelson{at}leeds.ac.uk

    • Sources of funding: ConvaTec UK Ltd, Hoeschst Roussel Ltd UK, and Chief Scientist Office, Scotland.

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