title: Potential interest of a new absorbable collagen membrane in the prevention of adhesions in paediatric cardiac surgery: a feasibility study.
abstract: BACKGROUND
  Open-heart surgery can result in adhesions, which can complicate resternotomy.
  
  
  OBJECTIVE
  To document the occurrence of adhesions after the use of a new collagen membrane; to evaluate its tolerability; and to compare surgical parameters with control patients.
  
  
  METHODS
  Paediatric patients who underwent cardiac surgery with the collagen membrane (Cova™ CARD; Biom'up, Saint Priest, France) were analysed retrospectively for levels of adhesion and tolerability. The times of dissection and intervention and the transfusion of packed red blood cells and haemostatic products were compared to a historic cohort who did not receive an anti-adhesion device.
  
  
  RESULTS
  From January 2010 to December 2011, 36 patients received a collagen membrane. Nineteen re-interventions were performed, after a mean of 169 days. No grade 3 adhesions were observed and no tolerability problems were reported. During re-interventions after more than 30 days, the propensity score-adjusted durations of dissection and the total process for patients with and without a collagen membrane were 32 vs 41 minutes and 151 vs 182 minutes, respectively (not significant). The mean quantities of red blood cells and biological glue administered in the two groups were 98 vs 139 mL and 1.2 vs 0.5 mL, respectively (not significant).
  
  
  CONCLUSIONS
  This feasibility study shows the potential use of the new membrane in paediatric patients, both in terms of prevention from severe adherence and tolerability. This is the first study of this membrane in humans. A prospective, controlled study is necessary to provide strong evidence of its efficiency.
authors.affiliation: Hospices Civils de Lyon, Groupement Hospitalier Est, Service Pharmaceutique, Bron, France; Hospices Civils de Lyon, Délégation à la Recherche Clinique et à l'Innovation, Cellule Innovation, Lyon, France; Université Claude-Bernard Lyon-1, UMR-CNRS 5510/MATEIS, Lyon, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Armoiry
authors.forename: Marie
authors.initials: M
authors.lastname: Viprey
authors.forename: Hélène
authors.initials: H
authors.lastname: Constant
authors.forename: Gilles
authors.initials: G
authors.lastname: Aulagner
authors.forename: Adeline S
authors.initials: AS
authors.lastname: Roux
authors.forename: Laure
authors.initials: L
authors.lastname: Huot
authors.forename: François
authors.initials: F
authors.lastname: Roubertie
authors.forename: Jean
authors.initials: J
authors.lastname: Ninet
authors.forename: Roland
authors.initials: R
authors.lastname: Henaine
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000367:Age Factors; D001672:Biocompatible Materials; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003094:Collagen / Q000009:adverse effects / Q000627:therapeutic use*; D017707:Erythrocyte Transfusion; D005240:Feasibility Studies; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D061646:Operative Time; D012086:Reoperation; D012189:Retrospective Studies; D013997:Time Factors; D000267:Tissue Adhesions / Q000517:prevention & control*; D014014:Tissue Adhesives / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D006490:Hemostatics; D014014:Tissue Adhesives; D003094:Collagen
keywords: Biomaterials; Biomatériaux; CI; Cardiac reoperation; Chirurgie; Collagen membrane; Complications; ECC; Membrane de collagène; Paediatric; Pédiatrie; RBC; Réintervention chirurgicale; SD; Surgery; confidence interval; ePTFE; expanded polytetrafluoroethylene; extracorporeal circulation; red blood cells; standard deviation