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 pain is a serious problem for elderly patients suffering from chronic leg ulcers, and it may lead to reduced wound healing rates and reduced quality of life. Biatain s -Ibu Non-adhesive (Coloplast A/S), a new pain-reducing moist wound healing dressing containing ibuprofen was tested for pain reduction, safety, and efficacy on 1012 patients in a single-blinded crossover study against Biatain Non-adhesive (Coloplast A/S). Pain was measured with a Numeric Box Scale before, during, and after dressing change. Quality of life was measured using the World Health Organization-5 Well-Being Index. Dressing moist wound healing properties such as absorption capacity and leakage were tested together with assessment of wound exudate and blood plasma content of ibuprofen. Use of the Biatain s -Ibu foam dressing correlated with a decrease in pain intensity scores from 7 in the run-in period to approximately 2.5 in the Biatain s -Ibu treatment phase. Quality of life measures were improved which together with the reduced pain could contribute to faster wound healing. The moist wound healing properties of Biatain s -Ibu were similar to that of the Biatain Non-adhesive and ulcer size was reduced by 24% during the treatment period. Neither side effects nor systemic plasma concentrations of ibuprofen were observed. These data indicate that Biatain s -Ibu could reduce persistent and temporary wound pain, increase Quality of life, was found safe to use, and had excellent moist wound healing properties. People 65 years of age and older constitute one of the fastest growing segments of the population in the USA and Europe. 1,2 Chronic leg ulceration is a serious problem among elderly people mostly caused by venous insufficiency. 3 Many patients with venous leg ulcers suffer persistent pain during the day, and part of these patients experience exacerbated pain at dressing change. 4 Therefore, more and more patients are having problems with painful venous ulcers. Hamer 5 found that 37.5% of patients with leg ulcers indicated that the worst complication was the associated pain. These patients can undertake light or very light activity only, are depressed or irritated, and have reduced social activities. 4 Furthermore, persistent pain disturbs sleep of 73% of the patients in a qualitative study by Noonan and Burge 4 and 50% had their mood affected. Thus, a rational wound management regime should reduce wound pain to alleviate its negative influence on patient’s everyday life. Compression bandaging of the lower leg is the cornerstone of chronic leg ulcer treatment in the absence of any significant arterial disease. 6 Leakage of exudate from ulcers has been shown to be a major problem causing distress to the patient 7 and affecting the general quality of life (QoL) for the patient as well. In addition, poor exudate handling is recognized as a barrier to granulation and epithelialization. 8 Consequently, optimal management of chronic painful leg ulcers includes selection of an appropriate treatment that addresses pain 9 minimizes venous stasis and promotes an optimal moist wound bed environ