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

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 IbuH) 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 (n598) or local best practice (n587). 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: 05no pain to 105worst 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 (pv0.0001 for both variables). Within the four most common ulcer aetiolgies, patients reported significantly more effective pain relief with ibuprofen foam treatment (venous: p50.009, mixed arterial venous: pv0.0001, arterial: p50.0009, and vasculitis: p50.009). In all groups, patients from the ibuprofen foam group reported lower pain intensities. The results were significant for patients with venous (pv0.002) and arterial (pv0.0001) 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. Key words: Ibuprofen, leg ulcer, occlusive dressings, pain management, wound healing Introduction Pain represents a major problem for patients with chronic wounds (1–5). Poor management of pain has been shown to affect patients’ quality of life (6,7) and potentially influences healing (8). Chronic pain in leg ulcers is often poorly managed (9), with the prevalence of pain reported as being as high as 64% (2). A participant in one study of painful leg ulcers described his/her situation as being ‘locked in a shell of pain’ (7). Almost 50% of patients in one study investigating the impact of dressings and cleansing agents could not use compression dressings because of the associated pain (8). People with ulcers of venous, arterial, mixed arterial venous, and vasculitis origin are reporting serious problems with wound pain (1,2). However, there is limited literature on the effect of active treatments in these patients. Foam dressings provide moisture balance to wounds and have been shown to have excellent absorbency properties with fewer dressing changes (10). Orally administered non-steroidal anti-inflammatory drugs, such as ibuprofen, are excellent for pain management, but their use can be precluded in some patients owing to weak blood circulation reducing the local effect, and side effects such as gatrointestinal bleeding and decreased renal function (11). Biatain IbuH (Coloplast A/S, Denmark) is a nonadhesive foam dressing that continually releases ibuprofen to the applied wound (7) relative to the exudate level of the wound. Previous studies in patients with leg ulcers have shown that use of ibuprofen foam (Ibu Foam) is associated with significantly reduced pain associated with leg ulcers (7,12,13). In addition, use of the Ibu Foam improved quality of life (12), reduced peri-wound erythema, and increased healthy granulation tissue