The WOCN Society 40th Annual Conference (June 21-25th, 2008)


2208

Efficacy and tolerance of a contact layer* and hydrocolloid dressing in the treatment of venous and mixed leg ulcers: results of randomized clinical study

Sylvie Meaume, MD, Hospital Charles Fox, Chef de Service Geriatrie - Pavillon l'Orbe, 7 avenue de la Republique, 94205 IVRY SUR SEINE, France, Patricia Senet, MD, Pavillon l'Orbe, Chef de Service Geriatrie, 7 avenue de la Republique, 94205 IVRY SUR SEINE, France, Michel Pannier, MD, CHU de Nantes, Chef de Serice de Chirurgie Plastique et Reparatrice, Immeuble Jean Monet, 30 Boulevard Jean Monet B.P. 1005, 44000 NANTES, France, and Serge Bohbot, MD, Laboratoires URGO, Medical Director, 49, rue Longvic, 21300 Chenove, France.

Introduction: If the etiological treatment of venous disease is well known (compression therapy), new classes of wound dressings have to be evaluated in the local management of leg ulcers compared with the reference dressings. A multicenter randomized clinical study was conducted to compare the efficacy, the tolerance, and the acceptability of a contact layer* and hydrocolloid dressing (control group) in the treatment of leg ulcers.  A medico-economic approach was associated in this trial.

Material and methods: Twenty (20) French dermatological and vascular medicine wards included 91 patients in this study. The patients were divided in two groups. The patients were followed up to 8 weeks on a weekly basis. Assessment included a clinical, planimetric and photography evaluation in association to a compression therapy for all patients.

Results: Baseline characteristics of the patients and the wounds were balanced in the 2 groups. A total of 497 evaluations and 1082 dressing changes were assessed. The efficacy of the evaluated dressings in regards to the reduction in wound surface area was considered equivalent in the 2 groups. The analysis of local tolerance (local adverse events) was significantly greater in the control group compared to the contact layer group (p=0.0039). The contact layer presented a higher clinical acceptability on several parameters (pain at removal, odor or maceration). Lastly, the collected medico-economic data was similar in the two groups.

Conclusion: This study has shown a better local tolerance and acceptability of a non-adherent lipido-colloid contact layer* than a standard hydrocolloid dressing in efficacy and cost in leg ulcers management.

 * Product used was Urgotul (Laboratoires URGO, Dijon, France) marketed in the U.S. as Restore Contact Layer with TRIACT Technology by Hollister Wound Care, LLC, Libertyville, IL.


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