Traitement des lésions cutanées sévères du siège chez le nouveau-né hospitalisé: Intérêt de la pâte Orabase™

Cholestyramine ointment is an hospital preparation used as a second-intention treatment Or severe perianal skin lesions. These preparations have to be declared to AFSSAPS. The aim of this study was to assess the equivalence of Orabase™, a marketed paste, with intention of substitution. A clinical trial was performed to evaluate the effectiveness of cholestyramine ointment versus Orabase™ paste. This study was conducted in the neonatalogy unit. The principal evaluation criterion was the time to clinical recovery. Nurses also gave their subjective evaluation of each product. Although 34 children were included in the study, the time to clinical recovery delay was evaluated in 28. Time to clinical recovery was 90.5 hours for the Cholestyramine ointment and 81 hours for Orabase™ paste. Concerning the subjective assessment, Orabase™ paste achieved a higher score than cholestyramine ointment (p<0.01). Orabase™ paste was considered to be equivalent to cholestyramine ointment.