Effect of an ibuprofen-releasing foam dressing on wound pain: a real-life RCT.

Author(s): Palao i Domenech R, Romanelli M, Tsiftsis DD, Slonkova V, Jortikka A, Johannesen N, Ram A, Persson LM, Altindas M, Orsted H, Schafer E

Affiliation(s): Department of Plastic Surgery, Hospital Vail d'Hebron, Barcelona, Spain. 17983rpd@comb.es

Publication date & source: 2008-08, J Wound Care., 17(8):342, 344-8.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To compare an ibuprofen-releasing foam dressing (Biatain Ibu, ColoplastA/S) with local best practice in the treatment of painful exuding wounds. METHOD: In this large-scale randomised comparative study, 853 patients were randomised to either ibuprofen-releasing foam (test) dressing (n=467) or local best practice (n=386). Primary endpoint was wound pain relief from day 1-7, assessed by the patients twice daily using a five-point verbal rating scale. Secondary endpoints were reduction in pain intensity from day 0-7 (assessed using an 11-point numeric box scale), quality of life (assessed using the WHO-5 well-being index and effect on health-related activities of daily living) and the incidence of adverse events. RESULTS: After seven days significantly more patients in the experimental group experienced relief from temporary and persistent pain and a reduction in pain intensity,when compared with patients in the local best practice group (p<0.0001). They also experienced a greater improvement in quality of life. The number of adverse events in both groups was low. CONCLUSION: The test dressing provided an appropriate wound healing environment, relieved temporary and persistent wound pain, and decreased pain intensity. It was also associated with an improvement in quality of life.