Ibuprofen slow-release foam dressing reduces wound pain in painful exuding wounds: preliminary findings from an international real-life study

J Dermatolog Treat. 2009;20(1):19-26. doi: 10.1080/09546630802178232.


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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Delayed-Action Preparations / pharmacology*
  • Delayed-Action Preparations / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • Ibuprofen / pharmacology*
  • Ibuprofen / therapeutic use
  • International Cooperation
  • Male
  • Middle Aged
  • Occlusive Dressings*
  • Pain Measurement
  • Patient Satisfaction
  • Probability
  • Reference Values
  • Sensitivity and Specificity
  • Severity of Illness Index
  • Skin Ulcer / diagnosis
  • Skin Ulcer / drug therapy*
  • Treatment Outcome
  • Vasculitis / diagnosis
  • Vasculitis / drug therapy*
  • Wounds and Injuries / diagnosis
  • Wounds and Injuries / drug therapy


  • Delayed-Action Preparations
  • Ibuprofen