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First Dressing with Ibuprofen is Launched

The world's first wound dressing that releases ibuprofen to help reduce pain was among the hot wound care topics discussed at the recent European Wound Management Association's (EWMA) annual meeting in Prague, Czech Republic. Biatain-Ibu from Coloplast (headquartered in Humlebaek, Denmark, with its US office in Marietta, GA) combines absorbent foam with the release of ibuprofen as the dressing comes into contact with wound fluid.

 

The dressing's foam base structure can absorb and evaporate large amounts of exudate from the wound bed to reduce leakage and maceration, according to the manufacturer. A continuous release of ibuprofen directly into the wound is the novel characteristic of the dressing. One dressing can manage exudate and release ibuprofen for up to 7 days. The ibuprofen dose administered in a single Biatain-Ibu dressing is 0.5 mg/cm2, which is equal to 50 mg in a standard 10 cm x 10 cm dressing. Coloplast initially launched the dressing in March 2006 at London's Royal College of Physicians in the United Kingdom. International studies have been conducted and presented on the new product.

 

The most recent study conducted by Jorgensen et al1 tested Biatain-Ibu for pain reduction, safety, and efficacy in 12 patients in a single-blinded crossover study against placebo. Biatain-Ibu foam dressing was found to be associated with a decrease in pain intensity scores; pain levels postplacebo were higher than the levels with the Biatain-Ibu treatment. Pain was also reduced at dressing change compared with placebo. The researchers observed that Biatain-Ibu offers similar wound healing properties to Biatain Nonadhesive, and patients' ulcer size was reduced by 24% during treatment. They concluded that Biatain-Ibu could reduce persistent and temporary wound pain and increase quality of life, that it was safe to use with no systemic effect, and that it showed successful moist wound healing properties.

 

A study published in the April issue of World Wide Wounds2 examined 10 patients with painful chronic venous leg ulcers who were treated for 6 dressing changes with Biatain-Ibu. These patients had experienced persistent and severe wound pain, accompanied by occasional intense spontaneous pain. Nine of the 10 patients reported pain reduction, improved mobility, and elevated mood during the study. Their pain intensity scores decreased during the study; however, they increased just 1 week after discontinuing treatment. The researchers concluded that use of this dressing significantly reduced wound pain and improved patients' health-related quality of life.

 

In a poster abstract presented at the 2006 Symposium for Advanced Wound Care in San Antonio, TX, Sibbald et al3 reported on their investigation of Biatain-Ibu in 24 patients at a wound care clinic in Canada. The 1-week study was designed to investigate whether Biatain-Ibu offered effective pain reduction and improved quality of life. Half the patients received the new dressing; the other half received local best-practice treatments. Collected data showed that pain intensity was significantly reduced in the Biatain-Ibu group and was also reduced at dressing change. The relative median ulcer size was decreased to 82% in this group, which was significantly better than the control group. The researchers also noted improved exudate management and increased mature granulation with the new dressing. They concluded that Biatain-Ibu decreased chronic wound pain in patients with leg ulcers, reduced pain intensity at dressing removal, and was associated with decreased periwound erythema and improved exudate management.

 

Biatain-Ibu is awaiting approval from the US Food and Drug Administration.

 

References

 

1. Jorgensen B, Friis GJ, Gottrup F. Pain and quality of life for patients with venous leg ulcers: proof of concept of the efficacy of Biatain-Ibu, a new pain reducing wound dressing. Wound Repair Regen 2006:14, 233-9. [Context Link]

 

2. Flanagan M, Vogensen H, Haase L. Case series investigating the experience of pain in patients with chronic venous leg ulcers treated with a foam dressing releasing ibuprofen. World Wide Wounds 2006; April 2006. [Context Link]

 

3. Sibbald RG, Coutts P, Fierheller M. Decreased chronic (persistent) wound pain with a novel sustained release ibuprofen foam dressing. Symposium for Advanced Wound Care, Poster presentation. San Antonio, TX; 2006. [Context Link]