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.
RCT Entities:
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.
Authors: Jo C Dumville; Trish A Gray; Catherine J Walter; Catherine A Sharp; Tamara Page; Rhiannon Macefield; Natalie Blencowe; Thomas Kg Milne; Barnaby C Reeves; Jane Blazeby Journal: Cochrane Database Syst Rev Date: 2016-12-20