| Autor: |
Gillet, Jean L, Guex, Jean J, Allaert, François A, Avouac, Bernard, Leger, Philippe, Blaise, Sophie, Marchand, Angélique, Maillard, Hervé, Simon, Magali, Amor, Cyrine B, Pasqualini, Marion |
| Předmět: |
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| Zdroj: |
Phlebology; Oct2019, Vol. 34 Issue 9, p611-620, 10p |
| Abstrakt: |
Objective: To evaluate the efficacy, safety and acceptability of an innovative two-component versus a well-established four-component compression systems in the management of venous leg ulcer. Method: Multicentre randomized controlled trial in patients with active venous leg ulcer. Patients were followed-up monthly for a maximum of 16 weeks. The primary endpoint was the complete healing rate at 16 weeks. Results: Ninety-two patients were randomized to either the two-component BIFLEX® Kit group (n = 49) or the four-component PROFORE® group (n = 43). In the full analysis set (n = 88), a complete healing rate of 48.9% and 24.4% was reported in BIFLEX® Kit versus PROFORE® groups, respectively (i.e. a superiority of 24.5%, p = 0.02). Acceptability of BIFLEX® Kit was higher from both the patients' and physicians' perspectives. Conclusion: The BIFLEX® Kit represents a valid alternative therapy in the management of venous leg ulcer according to its clinical efficacy, safety and acceptability with potential positive impacts on healthcare costs. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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