Phase II study evaluates a new composite dressing for managing venous leg ulcers, indicating safety and clinical performance benefits.
OBJECTIVES: A new composite dressing (Versiva, ConvaTec) combines three technologies: hydrocolloid, hydrofibre and a foam-film layer. This study aimed to assess the safety of the dressing in the management of patients with venous leg ulcers. Clinical performance was also assessed. METHOD: This multicentre, non-randomised, open-label, phase II study assessed the safety (via adverse-effect reporting) and performance, including weartime, absorption, dressing integrity, ease of use and wound progression, of Versiva. Up to 10 dressing changes were assessed within a five-week study period. RESULTS: In 75 dressing changes of 11 ulcers, the mean wear time was approximately five days. No or minimal leakage was observed in 81% of changes. In 93%, the dressing was 'very easy' to remove, with no trauma to surrounding skin. Most changes (77%) were painless. CONCLUSION: Versiva met or exceeded the investigators' expectations for exudate absorption, protection of peri-wound skin and reduction in wound pain and ulcer area. Healing or marked improvement was observed in 82% of leg ulcers within the five-week study. The relatively long wear-time of five days represents a cost-effective advantage for this dressing compared with other available adhesive foams for the management of chronic wounds.
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Daniels et al. (2002) studied this question.
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