title: [Serious adverse events after microbial sealant application in paediatric patients].
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To describe a case series of skin lesions in pediatric patients after using Integuseal(®) in cardiac surgery.
  
  
  METHODS
  Case series.
  
  
  RESULTS
  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).
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Using Integuseal(®) on children does not appear to be safe.
authors.affiliation: Service pharmacie, centre chirurgical Marie-Lannelongue, 133, avenue de la Résistance, 92350 Le Plessis-Robinson, France.
authors.forename: P
authors.initials: P
authors.lastname: Roy
authors.affiliation: Service pharmacie, centre chirurgical Marie-Lannelongue, 133, avenue de la Résistance, 92350 Le Plessis-Robinson, France.
authors.forename: A
authors.initials: A
authors.lastname: Loubière
authors.affiliation: Service pharmacie, centre chirurgical Marie-Lannelongue, 133, avenue de la Résistance, 92350 Le Plessis-Robinson, France.
authors.forename: T
authors.initials: T
authors.lastname: Vaillant
authors.affiliation: Service pharmacie, centre chirurgical Marie-Lannelongue, 133, avenue de la Résistance, 92350 Le Plessis-Robinson, France. Electronic address: b.edouard@ccml.fr.
authors.forename: B
authors.initials: B
authors.lastname: Édouard
mesh_terms: D000367:Age Factors; D006348:Cardiac Surgical Procedures / Q000379:methods; D002675:Child, Preschool; D000075202:Contraindications; D003487:Cyanoacrylates / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011182:Postoperative Care / Q000009:adverse effects*; D012307:Risk Factors; D012871:Skin Diseases / Q000209:etiology*; D013530:Surgical Wound Infection / Q000517:prevention & control
chemical_list: D003487:Cyanoacrylates
keywords: Cyanoacrylate; Device safety; Integuseal(®); Matériovigilance; Microbial sealant; Pediatrics; Produit filmogène; Pédiatrie