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Leg Ulcers and a New Foam Dressing: Results of Two French Multicenter Clinical Studies

Jean-Marc Bressieux, Centre Hospitalier de Troyes, Doctor, 101 Avenue Anatole France, TROYES, 10000, France, Jean-Luc Gerard, Private cabinet, Doctor, 23, bd Saint-Martin, Paris, France, Jean-Luc Schmutz, Centre Hospitalier de Nancy - Hôpital Fournier, Doctor, 36 Quai de la Bataille - C.O. - n° 34, Nancy, 54035, France, and Serge Bohbot, Laboratoires Urgo, Medical Director, 42 rue de Longvic, Chenove, 21300, France.

Leg ulcers related to venous disease present a real problem of public health. The therapeutic strategy of this pathology is based on two complimentary elements: compression therapy, and the topical care with dressings to absorb excess drainage and support the healing process. In order to evaluate the efficacy, tolerance, and acceptability of the Non Adhesive and Adhesive wound foam* in the local management of venous leg ulcers, two prospective, multicenter, non-comparative phase III open-label clinical studies were conducted in 30 French hospital dermatology and vascular medicine departments and private dermatology and phlebology practices. Patients were followed-up six weeks on a weekly basis including clinical evaluation, area tracings and photographs by the investigator. More than 100 patients, presenting with recurrent leg ulcers of less than 18 months duration were included in these two studies. The wound surface areas were between 3 to 50 cm2 (Non Adhesive foam study) and 3 to 40 cm2 (Adhesive foam study). In the two studies, the mean surface area reductions after 6 weeks of follow-up were about 40% and the mean dressing change frequency was more than 3 days. Good tolerance was observed in the two studies. Patient acceptance (comfort during dressing removal) and nursing acceptance (ease of use, condition of peri-wound skin) were recorded at each dressing change and will be described in the presentation. These results demonstrated that the local treatment of the venous leg ulcers with a new non- adhesive or adhesive wound foam* in conjunction with compression therapy allowed a good evolution of the healing process in these chronic wounds. The acceptance and tolerance of the products support their usefulness in the management of these challenging chronic wounds.

*Restore Foam Dressings with Triact Technology, Hollister Wound Care, Libertyville, IL Supported in part by Hollister Wound Care, LLC


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