Évènements indésirables graves à l’occasion de l’emploi d’un dispositif filmogène en pédiatrie

Abstract

Integuseal(®) is a cyanoacrylate-based medical device (IIa class), used in surgery after skin preparation to reduce bacterial contamination. It is not officially contraindicated for children. To describe a case series of skin lesions in pediatric patients after using Integuseal(®) in cardiac surgery. Case series. Between September 2012 and February 2013, 153 pediatric patients were treated by Integuseal(®) to prepare for a cardiac surgery in our center: 5 patients (2%) had serious cutaneous reactions. The average age of patients having had lesions is 16months (the youngest patient being 1month old and the oldest being 5years and 8months old). The risk factor in the development of skin lesion seems to be particularly related to the patient's age and sternal location. Other medical literature reports instances of cyanoacrylate intolerance in a variety of other situations. Using Integuseal(®) on children does not appear to be safe.