A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery

Andrew J. Lodge*, Winfield J. Wells, Carl L Backer, James E. O'Brien, Erle H. Austin, Emile A. Bacha, Thomas Yeh, William M. DeCampli, Philip T. Lavin, Samuel Weinstein

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

50 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)614-621
Number of pages8
JournalAnnals of Thoracic Surgery
Volume86
Issue number2
DOIs
StatePublished - Aug 2008

Funding

This work was supported by SyntheMed, Inc, Iselin, New Jersey, which provided financial support to the individual centers to cover study costs and maintained the central study database at its own expense. The authors would like to express their appreciation to Eli Pines, PhD, Vice President and Chief Scientific Officer of SyntheMed, Inc for his support and assistance. The sponsor, SyntheMed, Inc, provided the device used in this study at no cost to the study centers. The authors had full control of the design of the study, methods used, outcome parameters, analysis of data and production of the written report.

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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