A prospective, open-label study to assess the clinical performance of a foam dressing in the management of chronic wounds.

Polyurethane foam dressings are used to help absorb wound exudate while maintaining a moist wound environment. To assess the clinical performance of a foam dressing, a prospective, open-label evaluation of 57 outpatients (mean age 69 years) with delayed/non-healing wounds (one per patient, average duration 1.4 +/- 4.1 years) of different etiologies was conducted in 15 medical centers in Germany. Physicians assessed the clinical appearance of the wound bed, periwound skin, and exudate level at the beginning and final evaluation and dressing performance characteristics were rated. Patients were asked to assess their wound pain as none, mild, moderate, or strong. After three dressing changes (performed approximately 3 days apart), slough and necrotic tissue on the wound surface changed from an average of 54% (+/- 33%) to 29% (+/- 25%). At baseline, granulation tissue covered an average of 41% (+/- 31%) of the wound bed compared to 59% (+/- 24%) at the final assessment and the proportion of wounds assessed as heavily exudating decreased from 32% to 11%. During the evaluation, the proportion of patients without periwound skin problems increased from 49% to 66% and the percentage of patients with wound pain decreased from 45% to 26%. Between 80% and 90% of the participating physicians rated the product attributes assessed as "very good" or "good."