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 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 1 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

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

Cite this

Lodge, A. J., Wells, W. J., Backer, C. L., O'Brien, J. E., Austin, E. H., Bacha, E. A., ... Weinstein, S. (2008). A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery. Annals of Thoracic Surgery, 86(2), 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.",
author = "Lodge, {Andrew J.} and Wells, {Winfield J.} and Backer, {Carl L} and O'Brien, {James E.} and Austin, {Erle H.} and Bacha, {Emile A.} and Thomas Yeh and DeCampli, {William M.} and Lavin, {Philip T.} and Samuel Weinstein",
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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

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, 01.08.2008, p. 614-621.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery

AU - Lodge, Andrew J.

AU - Wells, Winfield J.

AU - Backer, Carl L

AU - O'Brien, James E.

AU - Austin, Erle H.

AU - Bacha, Emile A.

AU - Yeh, Thomas

AU - DeCampli, William M.

AU - Lavin, Philip T.

AU - Weinstein, Samuel

PY - 2008/8/1

Y1 - 2008/8/1

N2 - 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.

AB - 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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