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Clinically relevant pain relief with an ibuprofen‐releasing foam dressing: Results from a randomized, controlled, double‐blind clinical trial in exuding, painful venous leg ulcers
Author(s) -
Fogh Karsten,
Andersen Maibritt B.,
BischoffMikkelsen Morten,
Bause Renzo,
Zutt Markus,
Schilling Stephan,
Schmutz JeanLuc,
Borbujo Jesús,
Jimenez Juan A.,
Cartier Hugues,
Jørgensen Bo
Publication year - 2012
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1524-475x.2012.00844.x
Subject(s) - medicine , ibuprofen , evening , number needed to treat , randomized controlled trial , adverse effect , venous leg ulcer , anesthesia , surgery , confidence interval , relative risk , physics , astronomy , pharmacology
The objective of this 6‐week, 120‐patient, double‐blind, randomized, controlled trial was to investigate if a foam dressing with ibuprofen provided clinically relevant pain relief ( PAR ) for exuding, painful venous leg ulcers in comparison with a similar foam dressing without ibuprofen. Primary outcome parameter was PAR compared with baseline pain during the first 5 days of the investigation. PAR was registered by the patient morning and evening. Main end point was proportion of patients reporting a summed PAR score of at least 50% of the total maximum PAR (i.e., responders) and the corresponding number needed to treat ( NNT ). Wound‐related parameters such as ulcer healing, ulcer area reduction, and peri‐ulcer skin condition as well as adverse events were recorded during all 6 weeks of the investigation. PAR was significantly greater in the ibuprofen foam group than the comparator group ( p = 0.0438). There were 34% responders in the ibuprofen foam group vs. 19% in the comparator group ( NNT = 6.8). When evening data were analyzed separately to evaluate PAR over daytime, NNT was 5.3. Wound healing parameters and adverse events were comparable. In conclusion, in this study, the ibuprofen foam dressing provided clinically relevant PAR for patients with exuding, painful venous ulcers.