A novel bioresorbable film reduces postoperative adhesions after infant cardiac surgery.
Document Type
Article
Publication Date
8-2008
Identifier
DOI: 10.1016/j.athoracsur.2008.04.103
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.
Journal Title
The Annals of thoracic surgery
Volume
86
Issue
2
First Page
614
Last Page
621
MeSH Keywords
Cardiac Surgical Procedures; Female; Humans; Infant, Newborn; Male; Multivariate Analysis; Reoperation; Sternum; Tissue Adhesions; Wound Healing
Keywords
Cardiac Surgical Procedures; Multivariate Analysis; Reoperation; Sternum; Tissue Adhesions; Wound Healing
Recommended Citation
Lodge, A. J., Wells, W. J., Backer, C. L., O'Brien, J. E., Austin, E. H., Bacha, E. A., Yeh, T., Decampli, W. M., Lavin, P. T., Weinstein, S. A novel bioresorbable film reduces postoperative adhesions after infant cardiac surgery. The Annals of thoracic surgery 86, 614-621 (2008).
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