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

Research output: Contribution to journalArticle

32 Citations (Scopus)

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

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Sternotomy
Thoracic Surgery
Dissection
Thorax
Norwood Procedures
Control Groups
Cardiopulmonary Bypass
Multicenter Studies
Multivariate Analysis
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

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A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery. / Lodge, Andrew J.; Wells, Winfield J.; Backer, Carl L.; O'Brien, James E.; Austin, Erle H.; Bacha, Emile A.; Yeh, Thomas; DeCampli, William M.; Lavin, Philip T.; Weinstein, Samuel.

In: Annals of Thoracic Surgery, Vol. 86, No. 2, 08.2008, p. 614-621.

Research output: Contribution to journalArticle

Lodge, AJ, Wells, WJ, Backer, CL, O'Brien, JE, Austin, EH, Bacha, EA, Yeh, T, DeCampli, WM, Lavin, PT & Weinstein, S 2008, 'A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery', Annals of Thoracic Surgery, vol. 86, no. 2, pp. 614-621. https://doi.org/10.1016/j.athoracsur.2008.04.103
Lodge, Andrew J. ; Wells, Winfield J. ; Backer, Carl L. ; O'Brien, James E. ; Austin, Erle H. ; Bacha, Emile A. ; Yeh, Thomas ; DeCampli, William M. ; Lavin, Philip T. ; Weinstein, Samuel. / A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery. In: Annals of Thoracic Surgery. 2008 ; Vol. 86, No. 2. pp. 614-621.
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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.",
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AU - Wells, Winfield J.

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AU - Austin, Erle H.

AU - Bacha, Emile A.

AU - Yeh, Thomas

AU - DeCampli, William M.

AU - Lavin, Philip T.

AU - Weinstein, Samuel

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