A pilot (real-life) randomised clinical evaluation of a pain-relieving foam dressing: (ibuprofen-foam versus local best practice).

The aim of the study was to evaluate a novel foam dressing with continuous low-level release of ibuprofen (Biatain-Ibu foam dressing, Coloplast A/S, Humlebaek, Denmark) in persons with leg ulcers compared to local best practice. An open comparative and prospective block-randomised study of 24 patients was conducted in a Canadian wound clinic. Twelve patients were randomised to ibuprofen-foam and 12 patients to local best practice. The study population consisted of patients with chronic, painful exudating leg ulcers. The patients rated their wound pain intensity at baseline and after the first dressing application. Pain intensity in the morning and evening was rated during a period of 1 week using a numeric box scale (NBS). A t-test compared the main differences in pain intensity and a five-point verbal rating scale measured the patients' pain relief. At the last clinical visit, pain after dressing change was assessed using an NBS. In addition, wound size, percentage of healthy granulation tissue and the presence of peri-ulcer erythema, were (all) evaluated at inclusion and the end of the study. The nurses and patients both evaluated the relative dressing performance and exudate management at the last study visit. This study demonstrates that the ibuprofen-foam dressing decreased wound pain in patients with leg ulcers compared to best practice. The ibuprofen-foam dressing was associated with: diminished chronic pain between dressing changes, reduced acute pain at dressing change, increased healthy granulation tissue, decreased peri-wound erythema and excellent exudate handling capacity. It can be concluded from the results of the study that the combination of foam with a continuous low-dose release of ibuprofen may offer a valuable new therapeutic approach to the reduction of wound pain.

RCT Entities:   Population Interventions Outcomes