title: 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.
authors.affiliation: University Centre for Wound Healing, Odense University Hospital, Odense C, Denmark. fgottrup@post4.tele.dk
authors.forename: Finn
authors.initials: F
authors.lastname: Gottrup
authors.forename: Bo
authors.initials: B
authors.lastname: Jørgensen
authors.forename: Tonny
authors.initials: T
authors.lastname: Karlsmark
authors.forename: R Gary
authors.initials: RG
authors.lastname: Sibbald
authors.forename: Rytis
authors.initials: R
authors.lastname: Rimdeika
authors.forename: Keith
authors.initials: K
authors.lastname: Harding
authors.forename: Patricia
authors.initials: P
authors.lastname: Price
authors.forename: Vanessa
authors.initials: V
authors.lastname: Venning
authors.forename: Peter
authors.initials: P
authors.lastname: Vowden
authors.forename: Michael
authors.initials: M
authors.lastname: Jünger
authors.forename: Stephan
authors.initials: S
authors.lastname: Wortmann
authors.forename: Rita
authors.initials: R
authors.lastname: Sulcaite
authors.forename: Gintaris
authors.initials: G
authors.lastname: Vilkevicius
authors.forename: Terttu-Liisa
authors.initials: TL
authors.lastname: Ahokas
authors.forename: Karel
authors.initials: K
authors.lastname: Ettler
authors.forename: Monika
authors.initials: M
authors.lastname: Arenbergerova
mesh_terms: D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects; D001458:Bandages / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010146:Pain / Q000209:etiology* / Q000517:prevention & control*; D004364:Pharmaceutical Preparations; D014647:Varicose Ulcer / Q000150:complications*
chemical_list: D018712:Analgesics, Non-Narcotic; D004364:Pharmaceutical Preparations; D007052:Ibuprofen