Abstract

SERRA, N. et al. Effectiveness of the association of multilayer compression therapy and periwound protection with Cavilon^® (no sting barrier film) in the treatment of venous leg ulcers. Gerokomos [online]. 2010, vol.21, n.3, pp.124-130. ISSN 1134-928X.

Aim: appropriate treatment of venous leg ulcers is essential to improve the quality of life of patients. Compression therapy using multilayer bandages show to the best clinical results. In practice, it is used in combination with a suitable local care of the wound and periwound skin. The aim of this study was to evaluate the clinical effectiveness of a multi-layer compression bandage and the impact on it of the use of barrier film Cavilon^® in venous leg ulcers. Methods: controlled clinical trial, randomized, open, multicentre and pragmatic in Spain. All included patients were treated with compression therapy with the same multilayer bandages and randomized to the intervention group, treated with NSBF Cavilon^®, or to the control group. Up to 13 weekly visits were performed. The study was reviewed and approved by the institutional research board (IRB) of the 7 participating centres. Results: ninety eight patients were included in the study (49 in the intervention group and 49 in control group). At 4 weeks of treatment, the intervention group showed a mean ulcer size reduction (SD) greater than the control group (56.7% (30.3) vs. 45.5% (47.4), (p=0.087). At 12 weeks of treatment, differences were statistically significant (83.4% (31.1) vs. 71.6% (44.1), p=0.046). In the intervention group, 69.4% of patients reduced the ulcer area > 50% in the first 4 weeks of treatment, instead of 46.9% of patients in the control group (p <0.01). Conclusions: the clinical effectiveness of a multi-layer compression bandage (Coban^® 2) in patients with venous leg ulcers, assessed in terms of percentage reduction of area, is increased by concomitant use of a protective treatment of periwound skin with NSBF (Cavilon^®).

Keywords : Vascular ulcers; compression systems; multilayer bandage; periwound skin; barrier film; NSBF; controlled clinical trial.

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