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Ibuprofen slow-release foam dressing reduces wound pain in painful exuding wounds: Preliminary findings from an international real-life study.
Romanelli M, Dini V, Polignano R, Bonadeo P, Maggio G.
J Dermatolog Treat. 2008 Jul 14:1-7. [Epub ahead of print]
Background: Wound pain is a serious problem for people with chronic wounds. The aim of this real-life study was to compare the effect of a foam dressing that releases ibuprofen (Biatain Ibu((R))) with local best practice on the treatment of painful exuding wounds.
Methods: A total of 185 patients with painful exuding wounds were randomized to either ibuprofen foam treatment (n = 98) or local best practice (n = 87). The primary endpoint was pain relief over 7 days of treatment, assessed daily using a 5-point verbal rating scale (no relief, slight relief, moderate relief, lots of relief, and complete relief). Secondary endpoints included a total reduction in pain intensity for the whole study period (using an 11-point Numeric Box Scale: 0 = no pain to 10 = worst possible pain) and incidence of adverse events (AEs).
Results: More patients in the ibuprofen foam treatment group reported wound pain relief and lower wound pain intensity values after 7 days (p<0.0001 for both variables). Within the four most common ulcer aetiolgies, patients reported significantly more effective pain relief with ibuprofen foam treatment (venous: p = 0.009, mixed arterial venous: p<0.0001, arterial: p = 0.0009, and vasculitis: p = 0.009). In all groups, patients from the ibuprofen foam group reported lower pain intensities. The results were significant for patients with venous (p<0.002) and arterial (p<0.0001) leg ulcers. Two AEs were reported.
Conclusions: The ibuprofen foam represents an effective and safe alternative to local best practice in the management of painful exuding wounds.
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