Ibuprofen slow-release foam dressing reduces wound pain in painful exuding wounds: preliminary findings from an international real-life study.
BACKGROUND
Wound pain is a serious problem for people with chronic wounds. The aim of this real-life study was to compare the effect of a foam dressing that releases ibuprofen (Biatain Ibu) with local best practice on the treatment of painful exuding wounds.


METHODS
A total of 185 patients with painful exuding wounds were randomized to either ibuprofen foam treatment (n = 98) or local best practice (n = 87). The primary endpoint was pain relief over 7 days of treatment, assessed daily using a 5-point verbal rating scale (no relief, slight relief, moderate relief, lots of relief, and complete relief). Secondary endpoints included a total reduction in pain intensity for the whole study period (using an 11-point Numeric Box Scale: 0 = no pain to 10 = worst possible pain) and incidence of adverse events (AEs).


RESULTS
More patients in the ibuprofen foam treatment group reported wound pain relief and lower wound pain intensity values after 7 days (p < 0.0001 for both variables). Within the four most common ulcer aetiolgies, patients reported significantly more effective pain relief with ibuprofen foam treatment (venous: p = 0.009, mixed arterial venous: p < 0.0001, arterial: p = 0.0009, and vasculitis: p = 0.009). In all groups, patients from the ibuprofen foam group reported lower pain intensities. The results were significant for patients with venous (p < 0.002) and arterial (p < 0.0001) leg ulcers. Two AEs were reported.


CONCLUSIONS
The ibuprofen foam represents an effective and safe alternative to local best practice in the management of painful exuding wounds.
Romanelli
Marco
M
m.romanelli@med.unipi.it
Dini
Valentina
V
Polignano
Roberto
R
Bonadeo
Piero
P
Maggio
Giulio
G
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D003692:Delayed-Action Preparations / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007052:Ibuprofen / Q000494:pharmacology* / Q000627:therapeutic use; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D009779:Occlusive Dressings; D010147:Pain Measurement; D017060:Patient Satisfaction; D011336:Probability; D012016:Reference Values; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D012883:Skin Ulcer / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D014657:Vasculitis / Q000175:diagnosis / Q000188:drug therapy*; D014947:Wounds and Injuries / Q000175:diagnosis / Q000188:drug therapy
D003692:Delayed-Action Preparations; D007052:Ibuprofen