Ibuprofen slow-release foam dressing reduces wound pain in painful exuding wounds: Preliminary findings from an international real-life study

• Published in: The Journal of dermatological treatment Vol. 20; no. 1; pp. 19 - 26
• Main Authors: Romanelli, Marco, Dini, Valentina, Polignano, Roberto, Bonadeo, Piero, Maggio, Giulio
• Format: Journal Article
• Language: English
• Published: Oslo Informa UK Ltd 2009; Taylor & Francis
• Subjects: Aged; Aged, 80 and over; Analysis of Variance; Biological and medical sciences; Delayed-Action Preparations - pharmacology; Delayed-Action Preparations - therapeutic use; Dermatology; Female; Follow-Up Studies; Humans; Ibuprofen; Ibuprofen - pharmacology; Ibuprofen - therapeutic use; International Cooperation; leg ulcer; Male; Medical sciences; Middle Aged; Occlusive Dressings; pain management; Pain Measurement; Patient Satisfaction; Pharmacology. Drug treatments; Probability; Reference Values; Sensitivity and Specificity; Severity of Illness Index; Skin Ulcer - diagnosis; Skin Ulcer - drug therapy; Skin, nail, hair, dermoskeleton; Treatment Outcome; Vascular disorders of the skin; Vasculitis - diagnosis; Vasculitis - drug therapy; wound healing; Wounds and Injuries - diagnosis; Wounds and Injuries - drug therapy; Leg ulcer; Prostaglandin-endoperoxide synthase; Skin disease; wound healing; Enzyme; Controlled release form; Enzyme inhibitor; Lower limb; pain management; Wound; Non steroidal antiinflammatory agent; Pain; Foam; Healing agent; occlusive dressings; Ibuprofen; Dosage form; Occlusive dressing; Arylpropionic acid derivatives; Oxidoreductases
• ISSN: 0954-6634; 1471-1753
• DOI: 10.1080/09546630802178232

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.