title: A novel bioresorbable film reduces postoperative adhesions after infant cardiac surgery.
abstract: BACKGROUND
  Adhesions encountered in reoperative cardiac surgery can prolong operating time and increase risk. This study was designed to evaluate the ability of a novel bioresorbable barrier film to reduce adhesions in infants.
  
  
  METHODS
  A comparative, evaluator-masked, randomized, multicenter study design was used. Before chest closure, infants undergoing initial sternotomy for eventual staged palliative cardiac operations were randomized to barrier film placement (n = 54) or control (no treatment, n = 49) at 15 centers. At repeat sternotomy 2 to 13 months later, the extent and severity of adhesions at the investigational surgical site (ISS) were assessed. A four-grade adhesion severity scoring system was standardized as follows: none, mild (filmy, noncohesive, requiring blunt dissection), moderate (filmy, noncohesive, requiring sharp and blunt dissection), and severe (dense, cohesive, requiring extensive sharp dissection).
  
  
  RESULTS
  There were significantly fewer patients with any severe adhesions (29.6% vs 71.4%, p < 0.0001), and a significantly lower percentage of the ISS had severe adhesion involvement (21.1 +/- 36.9% vs 49.5 +/- 42.7%, p = 0.0005) in the barrier group compared with the control group at the second sternotomy. Delayed chest closure (p = 0.0101), Norwood procedure (p = 0.0449), and cardiopulmonary bypass (p = 0.0001) were univariate risk factors for more severe adhesions. Multivariate analysis revealed only control group to be a significant risk factor for more severe adhesions (p = 0.003). There were no statistically significant differences in adverse events between the groups. No adverse events were definitely attributed to the study device.
  
  
  CONCLUSIONS
  Use of a novel bioresorbable film was safe and effective in reducing the extent and severity of postoperative adhesions in infants undergoing repeat median sternotomy.
authors.affiliation: Division of Thoracic and Cardiovascular Surgery, Duke University Medical Center, Durham, North Carolina, USA. andrew.lodge@duke.edu
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Lodge
authors.forename: Winfield J
authors.initials: WJ
authors.lastname: Wells
authors.forename: Carl L
authors.initials: CL
authors.lastname: Backer
authors.forename: James E
authors.initials: JE
authors.lastname: O'Brien
authors.forename: Erle H
authors.initials: EH
authors.lastname: Austin
authors.forename: Emile A
authors.initials: EA
authors.lastname: Bacha
authors.forename: Thomas
authors.initials: T
authors.lastname: Yeh
authors.forename: William M
authors.initials: WM
authors.lastname: Decampli
authors.forename: Philip T
authors.initials: PT
authors.lastname: Lavin
authors.forename: Samuel
authors.initials: S
authors.lastname: Weinstein
mesh_terms: D006348:Cardiac Surgical Procedures; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D015999:Multivariate Analysis; D012086:Reoperation; D013249:Sternum / Q000601:surgery; D000267:Tissue Adhesions / Q000517:prevention & control*; D014945:Wound Healing