SAN FRANCISCO, CA -- March 25, 2003 -- A foam composite dressing is more effective in the treatment of venous leg ulcers than is the conventional hydrocellular foam pad, according to Arun Chakrabarty, MD.

"The new foam composite dressing performed very well, overall," stated Dr. Chakrabarty, of the department of dermatology at Boston University School of School of Medicine. "It was easy to apply, not traumatic on removal, and comfortable for the patient."

Dr. Chakrabarty and co-investigators presented the findings of a phase III comparative study comparing the two dressing modalities here at the 61^st Annual Meeting of the American Academy of Dermatology. The investigators were motivated to compare the two dressings because of the prevalence of leg ulcers in industrialised countries. They reported that leg ulcers are the most prevalent form of chronic wounds in such countries and that venous insufficiency causes 80 to 90% of such ulcers.

The 12-week multi-centre, prospective, randomised clinical trial study involved 197 subjects at 20 centres in the United States, Canada, and Europe. Because the results are ongoing, Dr. Chakrabarty reported on those of nine patients, four females and five males, from their own site at Boston University.

The investigators treated all subjects with compression therapy throughout the study. After randomisation, four subjects received treatment with the composite dressing and five with the hydrocellular foam pad. The investigative dressing consists of several layers designed to draw exudate away from the wound.

At the time of enrolment, the mean ulcer size in the treatment group was 14.32 cm²; in the control group, the mean ulcer size was 16.29 cm². The ulcer size decreased by an average of 59% in the treatment group; in the controls, the average decrease was 4%.

The investigators reported that the ulcer discharge was better contained in the treatment group, and they observed less draining. They also observed that dressings need to be changed once weekly in the treatment group and that the controls required dressing changes one and half times weekly.

The controls had more adverse events, such as pain with dressing changes, maceration of skin adjacent to the sound, and new ulcers, the investigators pointed out. Among the five controls, two discontinued, either because the ulcers were not improving or worsening. One patient in the treatment arm died after a non-emergent coronary artery bypass surgery during the study; the investigators concluded that this death was unrelated to the study.

"The foam composite dressing was designed to maintain a moist wound environment, to absorb excessive wound exudates, and to prevent maceration," Dr. Chakrabarty reported. "The dressing appeared to promote wound epithelialisation, to provide effective management of wound exudation, and decrease the frequency of dressing changes compared to the dressing control. These findings suggest that the new dressing offers benefits to the patient and clinician not currently offered by other foam dressings."

The study was funded by ConvaTec, a division of E.R. Squibb & Sons, L.L.C.

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