ORIGINAL RESEARCH–CLINICAL SCIENCE: Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double‐blind clinical investigation on the performance and safety

Abstract

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43-47, the patients in the ibuprofen-foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low-dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.

Health service pathways for patients with chronic leg ulcers: identifying effective pathways for facilitation of evidence based wound care

“…Evidence based guidelines and experts in wound management recommend coordinated specialised leg ulcer services involving care providers at multiple levels, providing continuity and standardisation of care, to obtain optimal outcomes for adults with leg or foot ulcers which fail to show signs of healing within 4–12 weeks [24,43,44]. However, this study found less than half of the participants had been referred to a secondary level of care before admission to the study clinics with an average ulcer duration of 22 weeks.…”

Chronic wounds – Recommendations for diagnostics and therapy

“…Dressing materials have experienced continuous and significant changes over the last years (29). They even might internalize different pharmaceutical compounds like antiseptics or analgetics to the wound surface (30). Debridement still ranks among the most important therapeutic approaches to reduce fibrin and bacterial burden and to induce wound healing by wound bed preparation.…”

Recent Developments in Topical Wound Therapy: Impact of Antimicrobiological Changes and Rebalancing the Wound Milieu

“…To overcome side effects of systemically applied analgetics, a combination of moisture-balancing foam dressings with the release of low-dose nonsteroidal anti-inflammatory drugs (NSAID), that is, ibuprofen, was developed representing a new therapeutic class of local pain-relieving dressings. Gottrup et al [5] evaluated the outcome of patients treated with ibuprofen foam in a randomized controlled double-blind clinical investigation. Wound pain intensity in patients with venous ulcers was significantly reduced with the ibuprofen foam compared to the pain-reducing effect of moist wound therapy alone.…”