PMID- 18622878 OWN - NLM STAT- MEDLINE DCOM- 20090901 LR - 20131121 IS - 1471-1753 (Electronic) IS - 0954-6634 (Linking) VI - 20 IP - 1 DP - 2009 TI - Ibuprofen slow-release foam dressing reduces wound pain in painful exuding wounds: preliminary findings from an international real-life study. PG - 19-26 LID - 10.1080/09546630802178232 [doi] AB - 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) 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. FAU - Romanelli, Marco AU - Romanelli M AD - m.romanelli@med.unipi.it FAU - Dini, Valentina AU - Dini V FAU - Polignano, Roberto AU - Polignano R FAU - Bonadeo, Piero AU - Bonadeo P FAU - Maggio, Giulio AU - Maggio G LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - J Dermatolog Treat JT - The Journal of dermatological treatment JID - 8918133 RN - 0 (Delayed-Action Preparations) RN - WK2XYI10QM (Ibuprofen) SB - IM MH - Aged MH - Aged, 80 and over MH - Analysis of Variance MH - Delayed-Action Preparations/*pharmacology/therapeutic use MH - Female MH - Follow-Up Studies MH - Humans MH - Ibuprofen/*pharmacology/therapeutic use MH - International Cooperation MH - Male MH - Middle Aged MH - *Occlusive Dressings MH - Pain Measurement MH - Patient Satisfaction MH - Probability MH - Reference Values MH - Sensitivity and Specificity MH - Severity of Illness Index MH - Skin Ulcer/diagnosis/*drug therapy MH - Treatment Outcome MH - Vasculitis/diagnosis/*drug therapy MH - Wounds and Injuries/diagnosis/drug therapy EDAT- 2008/07/16 09:00 MHDA- 2009/09/02 06:00 CRDT- 2008/07/16 09:00 PHST- 2008/07/16 09:00 [pubmed] PHST- 2009/09/02 06:00 [medline] PHST- 2008/07/16 09:00 [entrez] AID - 794947107 [pii] AID - 10.1080/09546630802178232 [doi] PST - ppublish SO - J Dermatolog Treat. 2009;20(1):19-26. doi: 10.1080/09546630802178232.