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 |
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| Authors: | Finn Gottrup MD DMSc Bo Jørgensen MD Tonny Karlsmark MD R. Gary Sibbald MD Rytis Rimdeika MD Keith Harding MB Patricia Price PhD Vanessa Venning DM Peter Vowden MD Michael Jünger MD Stephan Wortmann MD Rita Sulcaite MD PhD Gintaris Vilkevicius MD PhD Terttu‐Liisa Ahokas MD Karel Ettler MD PhD Monika Arenbergerova MD PhD |
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| Affiliation: | 1. University Centre for Wound Healing, Odense University Hospital, Odense C, Denmark,;2. Copenhagen Wound Healing Centre, H:S Bispebjerg University Hospital, Copenhagen NV, Denmark,;3. Wound Healing Clinic, Women's College Hospital, University of Toronto, Toronto, ON, Canada,;4. Department of Plastic and Reconstructive Surgery, Kaunas University of Medicine, Kaunas, Lithuania,;5. Wound Healing Research Unit, Cardiff University, Heath Park, Cardiff, UK,;6. Department of Dermatology, The Churchill Hospital, Oxford, UK,;7. Department of Vascular Surgery, Penthouse, Bradford Royal Infirmary, Bradford, UK,;8. Klinik und Poliklinik für Hautkrankheiten, Ernst‐Moritz‐Arndt University of Greifswald, Fleischmannstrasse Greifswald, Germany,;9. Facharzt für Dermatologie, Gesundheitszentrum, Blaubeuren, Germany,;10. Institute of Endocrinology, Kaunas University of Medicine, Kaunas, Lithuania,;11. Department of Vasculosurgery, Vilnius university Antakalnio hospital, Vilnius, Lithuania,;12. HUS, Iho‐ ja allergiasairaala, Ihotautien klinikka, Meilahdentie 2, Finland,;13. Department of Dermatology, Sokolska, Hradec Kralove, Czech Republic, and;14. Department of Dermatology, Charles University 3rd School of Medicine, Prague, Czech Republic |
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| 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. |
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