Open-Label Pilot Study of a New Foam Nonadhesive Dressing in the Management of Venous Leg Ulcers

PURPOSE:  To evaluate a new nonadhesive foam dressing performance when used under compression on venous leg ulcers in a wound care clinic setting.

METHODOLOGY:  Ten subjects were enrolled into this open-label, prospective, non-comparative evaluation. All subjects had at least one venous leg ulcer. Clinicians were surveyed regarding current wound care protocols and quality of life (QOL) for each subject at the start of treatment. Subject treatment was changed to incorporate the new nonadhesive foam dressing as the primary wound dressing. Periwound skin was treated with an alcohol-free skin protectant and the leg was bandaged with a 2-layer compression system. Subjects were followed for a maximum of four weeks. Data was analyzed using both descriptive and quantitative statistics.

RESULTS: A total of 10 subjects who completed 41 dressing changes participated in this study. Subjects were in the study for a median of 30 days (23-32 days). Median age was 63 years (34-84 years), 70% male, whose wounds were all present for >12 weeks with 30% of them present for > 1 year.  The median percent wound area change observed in this study at last visit relative to baseline was 37% reduction, with 80% of the subjects showing a wound reduction, half of which showed at least 50% reduction (one subject healed).  Nine subjects showed improvement in peri-wound maceration with 90% of subjects with no macerated skin by the last study visit.  Among the 40 dressing change assessments completed, the dressing was rated as easy to remove, maintained moist environment and did not cause damage to wound bed, periwound skin or surrounding tissue. 

CONCLUSIONS: Use of the nonadhesive foam dressing successfully led to wound area reduction in most of the wounds. The dressing was easy to apply and remove and was compatible with the alcohol-free barrier film and compression system used.